- The document provides a summary and details of the professional experience and qualifications of Steven P. Sanders as a senior packaging engineer and project manager with over 30 years of experience in the pharmaceutical, medical device, and consumer goods industries.
- Sanders has extensive experience managing complete packaging projects from concept to completion, developing primary and secondary packaging, launching new packaging lines, and performing validation work.
- His background includes packaging development, equipment design, project management, quality engineering, and serving as the liaison between customers and multiple equipment suppliers on integrated packaging lines.
Clyde McClelland is a versatile production supervisor with over 15 years of experience in the biotechnology and pharmaceutical industries. He has a proven track record of improving processes, reducing costs, ensuring compliance, and developing staff. His background includes positions with various companies where he implemented changes that increased productivity and efficiency.
Patrick St. Dennis has over 25 years of experience in product development, quality assurance, and sensory evaluation. He has held leadership roles managing teams and developing products at Estée Lauder. Most recently, he was the Director of Product Characterization at Estée Lauder, where he pioneered a descriptive sensory panel of licensed cosmetologists to provide guidance to new product development. He has expertise in strategic planning, project management, protocol development, and stakeholder communication.
Jacobs provides global integrated solutions for commissioning, qualification, and validation (CQV) services to clients in the biopharmaceutical industry. They offer a full range of CQV services from planning and programming through design, construction, startup, and validation to help clients throughout the project lifecycle. Jacobs takes a unified approach using dedicated CQV resources and multi-disciplinary teams to deliver comprehensive end-to-end solutions. They design, build, commission, qualify, and validate facilities efficiently through integrated project delivery and collaboration between design, construction, and CQV teams.
Jan Heaton has over 30 years of experience in laboratory and customer support roles. She possesses excellent communication skills and is reliable, punctual, and a clear thinker. Her career includes roles in quality control, microbiology, customer service, laboratory technician work, and medical laboratory assistance. She is seeking a new challenge to further develop her skills and enhance her career opportunities.
Kevin Cowan is a highly experienced Packaging Engineer with over 25 years of experience in packaging, materials, quality control, and package testing. He has held senior roles at Welch's and Unilever where he implemented cost-saving projects, developed new packages, established quality protocols, and launched numerous products on time and on budget.
Zeeshan Quddos is a highly experienced HSE Engineer with over 4 years of experience in various industries. He has expertise in health, safety, and environmental management, compliance, standards, and service delivery. Currently he works as an HSEQ Trainer/Advisor and has conducted trainings and implemented risk assessments for many companies.
Jose Candelario has 12 years of experience in the pharmaceutical industry with expertise in aseptic techniques, validation processes, equipment operation, and manufacturing of parenteral and lyophilized products. He has a Bachelor's in Network Technology and Applications Development and an Associate's in Electronic Technician. His most recent role was as a Manufacturing Supervisor at Pfizer where he supervised operators, revised SOPs, and ensured compliance.
Clyde McClelland is a versatile production supervisor with over 15 years of experience in the biotechnology and pharmaceutical industries. He has a proven track record of improving processes, reducing costs, ensuring compliance, and developing staff. His background includes positions with various companies where he implemented changes that increased productivity and efficiency.
Patrick St. Dennis has over 25 years of experience in product development, quality assurance, and sensory evaluation. He has held leadership roles managing teams and developing products at Estée Lauder. Most recently, he was the Director of Product Characterization at Estée Lauder, where he pioneered a descriptive sensory panel of licensed cosmetologists to provide guidance to new product development. He has expertise in strategic planning, project management, protocol development, and stakeholder communication.
Jacobs provides global integrated solutions for commissioning, qualification, and validation (CQV) services to clients in the biopharmaceutical industry. They offer a full range of CQV services from planning and programming through design, construction, startup, and validation to help clients throughout the project lifecycle. Jacobs takes a unified approach using dedicated CQV resources and multi-disciplinary teams to deliver comprehensive end-to-end solutions. They design, build, commission, qualify, and validate facilities efficiently through integrated project delivery and collaboration between design, construction, and CQV teams.
Jan Heaton has over 30 years of experience in laboratory and customer support roles. She possesses excellent communication skills and is reliable, punctual, and a clear thinker. Her career includes roles in quality control, microbiology, customer service, laboratory technician work, and medical laboratory assistance. She is seeking a new challenge to further develop her skills and enhance her career opportunities.
Kevin Cowan is a highly experienced Packaging Engineer with over 25 years of experience in packaging, materials, quality control, and package testing. He has held senior roles at Welch's and Unilever where he implemented cost-saving projects, developed new packages, established quality protocols, and launched numerous products on time and on budget.
Zeeshan Quddos is a highly experienced HSE Engineer with over 4 years of experience in various industries. He has expertise in health, safety, and environmental management, compliance, standards, and service delivery. Currently he works as an HSEQ Trainer/Advisor and has conducted trainings and implemented risk assessments for many companies.
Jose Candelario has 12 years of experience in the pharmaceutical industry with expertise in aseptic techniques, validation processes, equipment operation, and manufacturing of parenteral and lyophilized products. He has a Bachelor's in Network Technology and Applications Development and an Associate's in Electronic Technician. His most recent role was as a Manufacturing Supervisor at Pfizer where he supervised operators, revised SOPs, and ensured compliance.
Pack up your troubles - Packaging optimisation Anecto
Packaging for medical devices must meet strict validation criteria and regulations to ensure safety. Treating packaging as an afterthought can lead to costly failures and delays. Early consultation with packaging experts can help optimize packaging design to meet requirements for reliability, usability and cost while also considering transportation, markets and point of use. This prevents issues and ensures smooth validation.
Nancy A. Mangum has over 10 years of experience as a skilled bio-tech pharmaceutical material handler. She has expertise in operations and supply chain functions like shipping, receiving, and manufacturing. Mangum also has strong skills in multi-tasking, organization, customer service, problem-solving, and time management.
Pavan Kumar is a chemical engineer with over 5 years of experience in the pharmaceutical industry. He currently works as an Executive - Projects at Hospira Healthcare India Pvt. Ltd. in Visakhapatnam. In this role, he has led the installation, commissioning, and qualification of various process equipment and systems, including an emulsion preparation system. Pavan Kumar also coordinates equipment qualifications and validations, and has successfully managed projects coming in on time. He has participated in audits and received recognition for his successful transfer of Propofol production.
Our Group Profile, including vision, mission, history, values and financial highlights. Find out more about us on our website: http://www.sgs.com/en/Our-Company/About-SGS/SGS-in-Brief.aspx
Wayne Thomas has over 25 years of experience in materials management, manufacturing, and team leadership. He has led teams of up to 50 people and excels at continuous improvement, problem solving, and developing strategic goals and action plans. Some of his accomplishments include leading quality efforts between a plant and its largest customer to eliminate all complaints, developing and implementing plans to transition warehouse operations without impacting customers, and managing numerous start-up projects. He has expertise in areas such as Lean, ISO standards, production planning, and safety.
Sanford Fitelson has over 25 years of experience in packaging management, engineering, and operations. He has a proven track record of reducing costs by up to $1 million and identifying savings of over $2.5 billion. Fitelson has expertise in various packaging materials, development, testing, and production processes.
Lee Anthony Joynston provides a curriculum vitae summarizing his personal details, skills, academic and professional experience. He received a BSc in Biochemistry from the University of Sheffield in 2006, and his third year project involved investigating and purifying the McrC gene product. Since 2013, he has worked as the Production Team Leader at DRFP SmartSeal Ltd, a medical device manufacturing company, where he supervises staff and ensures compliance with quality standards. He has strong communication, organization, and laboratory skills developed through his education and career.
This document provides an executive summary and career profile for Dr. B. Guruswamy, who has over 17 years of experience in API research, process development, scale up, and life cycle management in the pharmaceutical industry. He is currently a Senior Principal Scientist at Neuland Laboratories in Hyderabad, India, where he leads a team of 20 scientists in multiple projects related to API synthesis and process optimization. The summary highlights his educational background, roles and responsibilities, career achievements, areas of expertise, publications, patents, and research experience.
Regie T. Candelaria has over 5 years of experience in quality control and research and development at Omnipack Industrial Corporation. He currently holds the position of Senior QC/R&D Analyst and has responsibilities such as raw material analysis, technical service to clients, and issuing raw material specifications. Previously he has also worked as a Junior Laboratory Analyst and Management Trainee. He has a Bachelor's degree in Chemical Engineering from Eastern Visayas State University.
This document is a resume for Jesus Arnoldo Castro, who is seeking a senior manufacturing or mechanical engineering position. He has over 30 years of experience in manufacturing engineering for medical devices. His qualifications include expertise in Six Sigma methodologies, FDA regulations, ISO standards, process validation, and quality assurance. He has significant experience in areas such as injection molding, extrusion, assembly operations, and clean room environments. His accomplishments demonstrate experience leading projects that improved processes, reduced costs and increased productivity and quality.
Margaret Davis is a dependable and motivated employee with 25 years of experience as a production worker at SunEdison, a solar and semiconductor manufacturer. She has excellent attendance, produces quality work while focusing on deadlines and processes, and easily adapts to changes. She gets along well with coworkers and management, learns quickly, and works well independently or as part of a team.
Moaz Hewedy has experience in biomedical engineering, simulation, electronics, and programming. He received a Bachelor's degree in Biomedical Engineering from NJIT. He has worked at Abbott Point of Care modifying procedures and procuring equipment. At Stryker, he developed packaging designs and assisted with validation processes. For his capstone project, he helped build a knee rehabilitation device and wrote documentation. He also served as President of the NJIT Muslim Student Association, where he planned strategies and events.
Robert Zeider has over 5 years of experience in quality assurance and manufacturing operations. He currently works as a Quality Analyst I at Shire Plc, where he is responsible for quality decisions during manufacturing, reviewing and revising documentation, and training others. Previously, he worked at his family's company, R.L. Zeider Incorporated, where he oversaw manufacturing of medical implants using CNC mills and wire EDMs. He holds a Bachelor's degree in Biology from California State University Channel Islands.
Stuart McDonald has over 30 years of experience in process engineering, production, and project management for companies in the chemicals and plastics industries. He has a proven track record of optimizing manufacturing processes to increase production and reduce waste. His areas of expertise include PVC production, computer simulation, and relief device sizing.
I am in quest of senior level assignments as Functional Lead - Quality Control/ Quality Assurance with an organization of repute in Denmark or nearby Schengen countries.
This document is a resume for Ndifreke 'Andy' Offong, who has over 5 years of experience in quality assurance and control inspection roles in the energy, medical, and agriculture industries. He is currently a Quality Assurance/Control Inspector at Socotherm in Houston, Texas, where he performs various inspection tests and ensures products meet standards. Previously he worked at Navian Energy and Oilfields Limited in Port Harcourt, Nigeria, where he inspected products and made arrangements for logistics and compliance with quality and safety standards. He has a Bachelor's degree in Microbiology from the University of Calabar in Nigeria.
Lynn Kostas is seeking an engineering position and has over 5 years of experience in production supervision, plant engineering, project engineering, new plant start up, and process safety management. She currently works as a Plant Engineer at Keystone Research & Pharmaceuticals where she has improved plant productivity by 25% and supervised the implementation of a new $10 million nail polish plant. Previously, she had an internship at Ashland Inc. where she developed models to optimize processes and equipment for a new plant. She holds a Bachelor of Science in Chemical Engineering from the University of Delaware.
Our Group Profile, including vision, mission, history, values and financial highlights. Find out more about us on our website: http://www.sgs.com/en/Our-Company/About-SGS/SGS-in-Brief.aspx
The document is a resume for David Sitty summarizing his background and qualifications for a position in downstream operations in the pharmaceutical/biotechnology industry. He has over 10 years of experience in manufacturing, documentation, production development, and process optimization. His resume lists his education in chemistry and work history including various roles at DesigneRx Pharmaceuticals and Genentech where he gained experience in areas like SOP writing, process equipment, chromatography, and cGMP facilities.
Sudeep Killedar is seeking a career enriching role in business development with a focus on the pharmaceutical industry, leveraging his nearly 9 years of experience in production, process enhancement, packaging, and research documentation for well-known pharmaceutical organizations. He has skills in enhancing production operations, optimizing resources, and ensuring compliance with quality standards and regulatory guidelines. The document provides details on his educational background and work experience in various roles with increasing responsibility in the pharmaceutical industry.
Medvantage International has acquired rights to a new vascular coupling device called CUVASLAR that represents an alternative to manual suturing for connecting arteries and veins. The device is expected to reduce surgical time, minimize errors from suturing, and improve patient outcomes. Medvantage plans to submit the device for FDA approval over the next year and market it to the 340,000 microsurgery procedures performed annually in the US.
Pack up your troubles - Packaging optimisation Anecto
Packaging for medical devices must meet strict validation criteria and regulations to ensure safety. Treating packaging as an afterthought can lead to costly failures and delays. Early consultation with packaging experts can help optimize packaging design to meet requirements for reliability, usability and cost while also considering transportation, markets and point of use. This prevents issues and ensures smooth validation.
Nancy A. Mangum has over 10 years of experience as a skilled bio-tech pharmaceutical material handler. She has expertise in operations and supply chain functions like shipping, receiving, and manufacturing. Mangum also has strong skills in multi-tasking, organization, customer service, problem-solving, and time management.
Pavan Kumar is a chemical engineer with over 5 years of experience in the pharmaceutical industry. He currently works as an Executive - Projects at Hospira Healthcare India Pvt. Ltd. in Visakhapatnam. In this role, he has led the installation, commissioning, and qualification of various process equipment and systems, including an emulsion preparation system. Pavan Kumar also coordinates equipment qualifications and validations, and has successfully managed projects coming in on time. He has participated in audits and received recognition for his successful transfer of Propofol production.
Our Group Profile, including vision, mission, history, values and financial highlights. Find out more about us on our website: http://www.sgs.com/en/Our-Company/About-SGS/SGS-in-Brief.aspx
Wayne Thomas has over 25 years of experience in materials management, manufacturing, and team leadership. He has led teams of up to 50 people and excels at continuous improvement, problem solving, and developing strategic goals and action plans. Some of his accomplishments include leading quality efforts between a plant and its largest customer to eliminate all complaints, developing and implementing plans to transition warehouse operations without impacting customers, and managing numerous start-up projects. He has expertise in areas such as Lean, ISO standards, production planning, and safety.
Sanford Fitelson has over 25 years of experience in packaging management, engineering, and operations. He has a proven track record of reducing costs by up to $1 million and identifying savings of over $2.5 billion. Fitelson has expertise in various packaging materials, development, testing, and production processes.
Lee Anthony Joynston provides a curriculum vitae summarizing his personal details, skills, academic and professional experience. He received a BSc in Biochemistry from the University of Sheffield in 2006, and his third year project involved investigating and purifying the McrC gene product. Since 2013, he has worked as the Production Team Leader at DRFP SmartSeal Ltd, a medical device manufacturing company, where he supervises staff and ensures compliance with quality standards. He has strong communication, organization, and laboratory skills developed through his education and career.
This document provides an executive summary and career profile for Dr. B. Guruswamy, who has over 17 years of experience in API research, process development, scale up, and life cycle management in the pharmaceutical industry. He is currently a Senior Principal Scientist at Neuland Laboratories in Hyderabad, India, where he leads a team of 20 scientists in multiple projects related to API synthesis and process optimization. The summary highlights his educational background, roles and responsibilities, career achievements, areas of expertise, publications, patents, and research experience.
Regie T. Candelaria has over 5 years of experience in quality control and research and development at Omnipack Industrial Corporation. He currently holds the position of Senior QC/R&D Analyst and has responsibilities such as raw material analysis, technical service to clients, and issuing raw material specifications. Previously he has also worked as a Junior Laboratory Analyst and Management Trainee. He has a Bachelor's degree in Chemical Engineering from Eastern Visayas State University.
This document is a resume for Jesus Arnoldo Castro, who is seeking a senior manufacturing or mechanical engineering position. He has over 30 years of experience in manufacturing engineering for medical devices. His qualifications include expertise in Six Sigma methodologies, FDA regulations, ISO standards, process validation, and quality assurance. He has significant experience in areas such as injection molding, extrusion, assembly operations, and clean room environments. His accomplishments demonstrate experience leading projects that improved processes, reduced costs and increased productivity and quality.
Margaret Davis is a dependable and motivated employee with 25 years of experience as a production worker at SunEdison, a solar and semiconductor manufacturer. She has excellent attendance, produces quality work while focusing on deadlines and processes, and easily adapts to changes. She gets along well with coworkers and management, learns quickly, and works well independently or as part of a team.
Moaz Hewedy has experience in biomedical engineering, simulation, electronics, and programming. He received a Bachelor's degree in Biomedical Engineering from NJIT. He has worked at Abbott Point of Care modifying procedures and procuring equipment. At Stryker, he developed packaging designs and assisted with validation processes. For his capstone project, he helped build a knee rehabilitation device and wrote documentation. He also served as President of the NJIT Muslim Student Association, where he planned strategies and events.
Robert Zeider has over 5 years of experience in quality assurance and manufacturing operations. He currently works as a Quality Analyst I at Shire Plc, where he is responsible for quality decisions during manufacturing, reviewing and revising documentation, and training others. Previously, he worked at his family's company, R.L. Zeider Incorporated, where he oversaw manufacturing of medical implants using CNC mills and wire EDMs. He holds a Bachelor's degree in Biology from California State University Channel Islands.
Stuart McDonald has over 30 years of experience in process engineering, production, and project management for companies in the chemicals and plastics industries. He has a proven track record of optimizing manufacturing processes to increase production and reduce waste. His areas of expertise include PVC production, computer simulation, and relief device sizing.
I am in quest of senior level assignments as Functional Lead - Quality Control/ Quality Assurance with an organization of repute in Denmark or nearby Schengen countries.
This document is a resume for Ndifreke 'Andy' Offong, who has over 5 years of experience in quality assurance and control inspection roles in the energy, medical, and agriculture industries. He is currently a Quality Assurance/Control Inspector at Socotherm in Houston, Texas, where he performs various inspection tests and ensures products meet standards. Previously he worked at Navian Energy and Oilfields Limited in Port Harcourt, Nigeria, where he inspected products and made arrangements for logistics and compliance with quality and safety standards. He has a Bachelor's degree in Microbiology from the University of Calabar in Nigeria.
Lynn Kostas is seeking an engineering position and has over 5 years of experience in production supervision, plant engineering, project engineering, new plant start up, and process safety management. She currently works as a Plant Engineer at Keystone Research & Pharmaceuticals where she has improved plant productivity by 25% and supervised the implementation of a new $10 million nail polish plant. Previously, she had an internship at Ashland Inc. where she developed models to optimize processes and equipment for a new plant. She holds a Bachelor of Science in Chemical Engineering from the University of Delaware.
Our Group Profile, including vision, mission, history, values and financial highlights. Find out more about us on our website: http://www.sgs.com/en/Our-Company/About-SGS/SGS-in-Brief.aspx
The document is a resume for David Sitty summarizing his background and qualifications for a position in downstream operations in the pharmaceutical/biotechnology industry. He has over 10 years of experience in manufacturing, documentation, production development, and process optimization. His resume lists his education in chemistry and work history including various roles at DesigneRx Pharmaceuticals and Genentech where he gained experience in areas like SOP writing, process equipment, chromatography, and cGMP facilities.
Sudeep Killedar is seeking a career enriching role in business development with a focus on the pharmaceutical industry, leveraging his nearly 9 years of experience in production, process enhancement, packaging, and research documentation for well-known pharmaceutical organizations. He has skills in enhancing production operations, optimizing resources, and ensuring compliance with quality standards and regulatory guidelines. The document provides details on his educational background and work experience in various roles with increasing responsibility in the pharmaceutical industry.
Medvantage International has acquired rights to a new vascular coupling device called CUVASLAR that represents an alternative to manual suturing for connecting arteries and veins. The device is expected to reduce surgical time, minimize errors from suturing, and improve patient outcomes. Medvantage plans to submit the device for FDA approval over the next year and market it to the 340,000 microsurgery procedures performed annually in the US.
Albert Brantley Jr. has over 30 years of experience in quality assurance and production roles in the pharmaceutical and chemical industries. His experience includes writing validation protocols and standard operating procedures, performing audits, developing quality systems, and managing production. He currently works as a Quality Engineer for Paxico LLC where he leads validation and compliance activities.
This document is a resume for Wendy Blanda, who has over 20 years of experience in pharmaceutical product development, formulation, and outsourcing. She has expertise in sustained release delivery systems, managing project teams, and ensuring successful scale-up and technology transfer. Some of her accomplishments include outsourcing formulation development for five projects, implementing a quality by design strategy, and championing a new formulation that enabled patients to receive a more tolerable treatment. She currently works as an Associate Director of Formulation Technologies.
Carmella Moody has over 30 years of experience in regulatory affairs, project management, and quality assurance for pharmaceutical and biotechnology products. She has directed regulatory strategies and submissions to the FDA and international agencies. Her experience includes developing regulatory dossiers, managing clinical trials, gaining regulatory approvals, and developing quality systems. Currently she is the Director of Regulatory Affairs at Pearl Therapeutics, where she is responsible for submissions to approval COPD products.
- Bharat Adarkar has over 20 years of experience in packaging development, validation, and technology transfer for pharmaceutical, medical device, and consumer products industries.
- He held senior roles at various companies where he led packaging engineering, validation, and global technical services teams.
- Adarkar has extensive experience with packaging development and validation of oral solid dosages, injectables, liquids, ointments, creams, and medical devices across various markets and geographies.
Kent D. Waldron is seeking a position as a Computer System and Process Validation Specialist. He has over 30 years of experience in validation engineering, quality engineering, and laboratory management. Currently, he is a Senior Staff Validation Engineer at Stryker Orthopaedics, where he is responsible for maintaining, improving, and promoting the validation process. He has extensive experience managing validation projects and teams. He is proficient with statistical software and statistical process control methods.
Hanife Akin has over 15 years of experience in pharmaceutical manufacturing operations and leadership. She currently serves as Senior Director of Pharmaceutical Manufacturing at Stason Pharmaceuticals, where she oversees manufacturing, technical operations, and other departments. Previously, she held roles with increasing responsibility at other pharmaceutical companies, managing projects, process improvement initiatives, and validation activities. Akin has expertise in various manufacturing processes and dosage forms. She is a skilled leader and problem solver with strengths in project management, team building, and strategic planning.
Farm is an ISO 13485-certified and FDA-compliant product development consultancy with over 40 years of experience helping medical, life sciences, and consumer healthcare companies. It offers expertise in areas like user research, engineering, design, and regulatory compliance. Farm helps clients design devices that are safe, easy to use and effective by employing research, usability testing, and a process-driven development approach.
Nancy Trafelet has over 25 years of experience in packaging engineering and project management. She currently works as an Associate Manager of Development Engineering Packaging at S.C. Johnson, where she focuses on product value optimization. Previously, she held packaging engineering and research roles at Sealed Air/Diversey and S.C. Johnson. She has expertise in plastics, packaging formats, testing, and sustainability.
Brendan Naughton has 9 years of experience in quality assurance roles within the medical device industry. He has worked at Steripack Ireland and Boston Scientific Ireland, taking on roles such as quality engineer, validation engineer, and quality technician. His experience includes activities like design reviews, change management, testing, audits, and investigations. Naughton holds a Higher Diploma in Quality Assurance from NUI Galway and a BSC in Forensic Science from the University of Glamorgan.
Christine Egan has over 15 years of experience in healthcare IT, specializing in pharmacy systems and electronic health records. She has extensive experience implementing, customizing, and supporting Cerner applications including PharmNet, CPOE, and medication administration. Her background includes roles as a consultant, analyst, and project manager where she has led teams and managed complex clinical implementations.
Karthikeyan Gopal has extensive experience in product design, development, risk management and project management for medical devices. He has worked on projects involving infusion pumps, consumables, combination products and more. His skills include systems engineering, design engineering, validation engineering, risk management, CAD, requirements management, and experience with various medical device standards and regulations. He has held roles at companies such as HCL Technologies, Hospira, American Medical Systems, and Baxter.
Mark Anthony Lewandowski has extensive experience in product development, project management, technical writing, and medical communication in the pharmaceutical industry. He has a PharmD degree and focuses on cardiovascular medicine and endocrinology. His career includes roles managing new product development, responding to medical information requests, and presenting on drug therapies.
Walter King is a seasoned senior R&D executive with over 30 years of experience in medical device and diagnostic product development. He has a proven track record of successfully directing projects from research through product launch on time and on budget. Key accomplishments include overseeing development of personalized diagnostic tests and medical devices that were paramount in the sale of two companies. He possesses strong leadership skills and experience managing multi-disciplinary teams across major companies.
The document provides a summary of N. Murugesan's professional experience and qualifications. He has over 3 decades of experience in project management, plant operations, and maintenance for pharmaceutical and chemical plants. Currently he is the VP of Operations for a contract manufacturing pharmaceutical company in Sikkim, India, where he oversaw the successful setup and commissioning of a new greenfield pharmaceutical plant worth Rs. 50 crore. He has extensive expertise in installing, testing, commissioning, and maintaining a wide range of pharmaceutical and chemical equipment.
This document is a resume for Mayra I. Casiano summarizing her experience in the medical device and pharmaceutical industries. She has over 20 years of experience in manufacturing, process/packaging, technical services, and validation. Some of her responsibilities have included leading manufacturing operations, implementing technology transfers, ensuring regulatory compliance, and authoring standard operating procedures. She is proficient in validation protocols for facilities, equipment, and processes.
Thao Vi Nguyen has over 20 years of experience in medical device research and development, manufacturing, and quality control. She has worked for several companies developing devices for gastrointestinal disease, sleep apnea, fecal incontinence, and cardiac ablation. Her skills include laser welding, polymer fusing, benchtop testing, data collection, report writing, training, and ensuring compliance with FDA and ISO regulations. She has received awards for her work from Boston Scientific and other employers.
James Jantschek has over 25 years of experience in operations management, lean manufacturing, project management, quality control, and logistics. He has held positions such as Production Manager, Quality Manager, and Logistics Manager at several companies in industries including manufacturing of HVAC equipment, aerospace/defense filtration systems, pharmaceutical packaging, medical devices, and wound care products. Throughout his career, he has implemented lean initiatives like 5S, Kaizen events, Kanbans, and quality systems to reduce costs and improve efficiencies.
Bob Price is a mechanical engineer with over 20 years of experience in product and process development for the medical device industry. He has experience designing components and fixtures, transferring products to manufacturing, and ensuring products meet necessary standards through testing. His skills include product development, process development, validation testing, CAD and machine shop skills. He is seeking a role where he can utilize his engineering and manufacturing experience.
Understanding Inductive Bias in Machine LearningSUTEJAS
This presentation explores the concept of inductive bias in machine learning. It explains how algorithms come with built-in assumptions and preferences that guide the learning process. You'll learn about the different types of inductive bias and how they can impact the performance and generalizability of machine learning models.
The presentation also covers the positive and negative aspects of inductive bias, along with strategies for mitigating potential drawbacks. We'll explore examples of how bias manifests in algorithms like neural networks and decision trees.
By understanding inductive bias, you can gain valuable insights into how machine learning models work and make informed decisions when building and deploying them.
Electric vehicle and photovoltaic advanced roles in enhancing the financial p...IJECEIAES
Climate change's impact on the planet forced the United Nations and governments to promote green energies and electric transportation. The deployments of photovoltaic (PV) and electric vehicle (EV) systems gained stronger momentum due to their numerous advantages over fossil fuel types. The advantages go beyond sustainability to reach financial support and stability. The work in this paper introduces the hybrid system between PV and EV to support industrial and commercial plants. This paper covers the theoretical framework of the proposed hybrid system including the required equation to complete the cost analysis when PV and EV are present. In addition, the proposed design diagram which sets the priorities and requirements of the system is presented. The proposed approach allows setup to advance their power stability, especially during power outages. The presented information supports researchers and plant owners to complete the necessary analysis while promoting the deployment of clean energy. The result of a case study that represents a dairy milk farmer supports the theoretical works and highlights its advanced benefits to existing plants. The short return on investment of the proposed approach supports the paper's novelty approach for the sustainable electrical system. In addition, the proposed system allows for an isolated power setup without the need for a transmission line which enhances the safety of the electrical network
Batteries -Introduction – Types of Batteries – discharging and charging of battery - characteristics of battery –battery rating- various tests on battery- – Primary battery: silver button cell- Secondary battery :Ni-Cd battery-modern battery: lithium ion battery-maintenance of batteries-choices of batteries for electric vehicle applications.
Fuel Cells: Introduction- importance and classification of fuel cells - description, principle, components, applications of fuel cells: H2-O2 fuel cell, alkaline fuel cell, molten carbonate fuel cell and direct methanol fuel cells.
Redefining brain tumor segmentation: a cutting-edge convolutional neural netw...IJECEIAES
Medical image analysis has witnessed significant advancements with deep learning techniques. In the domain of brain tumor segmentation, the ability to
precisely delineate tumor boundaries from magnetic resonance imaging (MRI)
scans holds profound implications for diagnosis. This study presents an ensemble convolutional neural network (CNN) with transfer learning, integrating
the state-of-the-art Deeplabv3+ architecture with the ResNet18 backbone. The
model is rigorously trained and evaluated, exhibiting remarkable performance
metrics, including an impressive global accuracy of 99.286%, a high-class accuracy of 82.191%, a mean intersection over union (IoU) of 79.900%, a weighted
IoU of 98.620%, and a Boundary F1 (BF) score of 83.303%. Notably, a detailed comparative analysis with existing methods showcases the superiority of
our proposed model. These findings underscore the model’s competence in precise brain tumor localization, underscoring its potential to revolutionize medical
image analysis and enhance healthcare outcomes. This research paves the way
for future exploration and optimization of advanced CNN models in medical
imaging, emphasizing addressing false positives and resource efficiency.
Embedded machine learning-based road conditions and driving behavior monitoringIJECEIAES
Car accident rates have increased in recent years, resulting in losses in human lives, properties, and other financial costs. An embedded machine learning-based system is developed to address this critical issue. The system can monitor road conditions, detect driving patterns, and identify aggressive driving behaviors. The system is based on neural networks trained on a comprehensive dataset of driving events, driving styles, and road conditions. The system effectively detects potential risks and helps mitigate the frequency and impact of accidents. The primary goal is to ensure the safety of drivers and vehicles. Collecting data involved gathering information on three key road events: normal street and normal drive, speed bumps, circular yellow speed bumps, and three aggressive driving actions: sudden start, sudden stop, and sudden entry. The gathered data is processed and analyzed using a machine learning system designed for limited power and memory devices. The developed system resulted in 91.9% accuracy, 93.6% precision, and 92% recall. The achieved inference time on an Arduino Nano 33 BLE Sense with a 32-bit CPU running at 64 MHz is 34 ms and requires 2.6 kB peak RAM and 139.9 kB program flash memory, making it suitable for resource-constrained embedded systems.
DEEP LEARNING FOR SMART GRID INTRUSION DETECTION: A HYBRID CNN-LSTM-BASED MODELgerogepatton
As digital technology becomes more deeply embedded in power systems, protecting the communication
networks of Smart Grids (SG) has emerged as a critical concern. Distributed Network Protocol 3 (DNP3)
represents a multi-tiered application layer protocol extensively utilized in Supervisory Control and Data
Acquisition (SCADA)-based smart grids to facilitate real-time data gathering and control functionalities.
Robust Intrusion Detection Systems (IDS) are necessary for early threat detection and mitigation because
of the interconnection of these networks, which makes them vulnerable to a variety of cyberattacks. To
solve this issue, this paper develops a hybrid Deep Learning (DL) model specifically designed for intrusion
detection in smart grids. The proposed approach is a combination of the Convolutional Neural Network
(CNN) and the Long-Short-Term Memory algorithms (LSTM). We employed a recent intrusion detection
dataset (DNP3), which focuses on unauthorized commands and Denial of Service (DoS) cyberattacks, to
train and test our model. The results of our experiments show that our CNN-LSTM method is much better
at finding smart grid intrusions than other deep learning algorithms used for classification. In addition,
our proposed approach improves accuracy, precision, recall, and F1 score, achieving a high detection
accuracy rate of 99.50%.
Introduction- e - waste – definition - sources of e-waste– hazardous substances in e-waste - effects of e-waste on environment and human health- need for e-waste management– e-waste handling rules - waste minimization techniques for managing e-waste – recycling of e-waste - disposal treatment methods of e- waste – mechanism of extraction of precious metal from leaching solution-global Scenario of E-waste – E-waste in India- case studies.
CHINA’S GEO-ECONOMIC OUTREACH IN CENTRAL ASIAN COUNTRIES AND FUTURE PROSPECTjpsjournal1
The rivalry between prominent international actors for dominance over Central Asia's hydrocarbon
reserves and the ancient silk trade route, along with China's diplomatic endeavours in the area, has been
referred to as the "New Great Game." This research centres on the power struggle, considering
geopolitical, geostrategic, and geoeconomic variables. Topics including trade, political hegemony, oil
politics, and conventional and nontraditional security are all explored and explained by the researcher.
Using Mackinder's Heartland, Spykman Rimland, and Hegemonic Stability theories, examines China's role
in Central Asia. This study adheres to the empirical epistemological method and has taken care of
objectivity. This study analyze primary and secondary research documents critically to elaborate role of
china’s geo economic outreach in central Asian countries and its future prospect. China is thriving in trade,
pipeline politics, and winning states, according to this study, thanks to important instruments like the
Shanghai Cooperation Organisation and the Belt and Road Economic Initiative. According to this study,
China is seeing significant success in commerce, pipeline politics, and gaining influence on other
governments. This success may be attributed to the effective utilisation of key tools such as the Shanghai
Cooperation Organisation and the Belt and Road Economic Initiative.
1. STEVEN P. SANDERS
7648 Ashmont Circle
Tamarac, Florida 33321
CELL: 609-647-3742 E-MAIL: spsndrs@gmail.com
_______________________________________________________________________
SUMMARY
Senior Packaging, Project Engineering, Quality Engineering, and Project Manager with significant
experience in the Pharmaceutical, Biotechnology, Medical Device, Cosmetic, and Diagnostic
industries.
Handled numerous complete Packaging projects from concept to completion.
Extensive hands on packaging development and equipment design experience with liquids, creams,
ointments, blisters, secondary packaging, etc.
Launched new packaging lines, including startup, commissioning, and Validation.
Involved with various packaging equipment including blister machines, bottlers, washers, fillers,
cappers, labelers, sterilizers, cartoners, case packers, robots, vision systems, wrappers, palletizers,
and customized packaging machinery.
Integrated multiple packaging machines into full packaging lines, creating interactive communication
handshakes between machines from various suppliers.
Performed packaging validations. Wrote and executed FAT, IQ/OQ, and PQ protocols and test
reports.
Excellent team player and project leader. Work and communicate well with Management, vendors,
and operational personnel.
Proven track record of successfully meeting goals within budgets and on time.
EXPERIENCE
DEPUY ORTHOPAEDICS (Johnson & Johnson)/ACRO SERVICES, Raynham, MA Oct 2014 – Present
Quality Engineer III
Assigned by Acro Services as a Consultant to DePuy Orthopaedics, a division of Johnson & Johnson, to
develop all relevant protocols and lead the efforts to validate equipment, software, and systems required to add
2D barcodes to all of the company’s medical implant devices. Projects involved adding and validating
automated systems for engraving and/or laser etching 2D barcodes and OCR human readable codes onto
plastic and metallic medical Class 2 and Class 3 implant devices, as well as automated verification of these
codes via barcode scanners and vision systems. Validations resulted in FDA submissions and the review of all
documents associated with these projects, and ultimately gaining FDA approval to fully implement. Developed
and authored complex validation (Process Verification and Process Qualification) protocols and risk
assessment (PFMEA) documents, and authored summary reports after participating in validation efforts.
Organized and provided full document packages for FDA submissions.
ASTRA ZENECA/OXFORD GLOBAL RESOURCES, Westborough, MA May 2014 – Aug 2014
Project Engineer
Assigned by Oxford Global Resources as a Consultant to Astra Zeneca to help manage, coordinate, and
complete their major project of installing and validating two new automated packaging lines with multiple
equipment to replace older outdated packaging lines for the production of Pulmicort Respules.
KRAFT FOODS/ EQUITY PACKAGING, INC. Tarrytown, NY April 2013 – Nov 2013
Senior Packaging Equipment Engineer
Assigned by Equity Packaging, Inc. as a Consultant to Kraft Foods for Kraft’s Packaging Equipment
Development group. Researching and developing packaging equipment and methods required to produce a
new coffee product in a new container and suggesting Proof of Principle concepts, costs, and timing.
2. INDEPENDENT PACKAGING CONSULTING March 2008 – April 2013
Worked on various packaging equipment and component projects, and as a Commissioning/Validation
Specialist for various company clients such as Teva Animal Health, Bayer Animal Health, and Mylan Labs at
the clients’ manufacturing plants
SYSTECH INTERNATIONAL, Cranbury, NJ March 2007 – Feb 2008
Project Manager
Managed all aspects of numerous projects simultaneously in support of sales, installation, and implementation
of company products and solutions, involving Vision, Serialized Product Tracking, and RFID. Primary post-sale
contact with company customers and OEM’s; including Wyeth Labs, Merck, Genzyme, Roche Diagnostics,
Baxter Healthcare, Hospira, TEVA Pharmaceuticals, Boehringer-Ingelheim, Watson Labs, Genentech, and
Lilly. Managed the entire scope and requirements of projects and served as liaison between team members
and the Customer.
Acted as the main customer contact in the post-sales project delivery phase. Created and maintained
customer relationships; established and managed customer expectations for entire projects.
Continually updated management about potential project slippage, budget over runs, and final product
quality issues.
Executed NOC process to prevent project scope creep.
SCHERING-PLOUGH CORP., Kenilworth, NJ Oct. 2004 – Feb. 2007
Manager Mfg. Maintenance Compliance
Responsibilities included assisting in achieving compliance with programs used within the Kenilworth NJ
Manufacturing Maint. and Engineering Departments and the adherence to formal SOP’s and policies. Managed
the Technical Training Dept, which trained Packaging Mechanics in Procedures, Packaging Equipment Set-
Up/Change-Over and Maintenance requirements, and cGMP compliance. Managed the creation and approval
of Packaging Equipment and Packaging Line Manuals used in the training of Packaging Mechanics.
CARDINAL HEALTH, Philadelphia, PA 2002 – Oct. 2004
Contract Packager of Prescription Drugs and Biomedical Products.
Senior Project Engineer
Managed complex equipment/automation projects for client products. Prepared Factory and Site Acceptance
Test protocols, Installation/Operation and Production Qualification Protocols, in
accordance with FDA requirements and implemented. Supported ongoing production by troubleshooting.
Purchased equipment for, and coordinated the successful installation of, two major automated integrated
packaging lines for the production of Amgen’s major injectable drug for the treatment of Arthritis, Enbrel.
Equipment included assembly machines, thermoformers, automated robotic feeders, cartoners, insert
feeders, labelers, case packers, checkweighers, and vision systems. Completed project consistent with
the launch date of the product.
Purchased equipment for and coordinated the successful installation of major automated integrated
packaging lines for the production of Biogen’s major injectable drug for the treatment of Multiple Sclerosis,
Liquid Avonex. Equipment included assembly machines, thermoformers, automated robotic feeders,
cartoners, labelers, case packers, and vision systems. Completed project consistent with the launch date
of the product.
CARTER-WALLACE, INC., Cranbury, NJ 1983 - 2002
Manufacturer of Health Care products, Prescription Drugs, Clinical Diagnostic
products, and Animal Care products.
Director of Package Engineering (Corporate)
Managed and coordinated the Corporate Package Engineering/Development group,
interfacing with Divisional Production and Engineering Management (Domestic &
International) to develop, justify and implement new or revised primary and secondary
packages, products, and packaging lines. Managed the specification system and interacted
with Production, Marketing, R&D, Purchasing, Operations, and Q.C. Departments. Prepared and
submitted annual budgets and Capital Expenditures for all packaging equipment and component
projects. Resolved component quality issues, and proposed and completed Cost/Profit Improvement projects.
Reported to the Corporate Vice-President of Engineering. Among numerous highlights:
3. Purchased and installed 6 new condom foiling and cartoning lines to fulfill the project requirements for a
new Trojan state-of-the-art condom plant in Colonial Heights, Virginia. Relocated all existing packaging
lines from old Trenton NJ plant simultaneously. Overall project savings for establishing this new plant was
$9 million dollars annually.
Suggested, justified, and implemented new high speed automated valve/capping machine for Astelin, a
prescription nasal de-congestant, with projected annual savings of $200,000.
Implemented the conversion of Arrid Solid Antiperspirants from round to oval containers, and engineered
packaging line and equipment changes required. Successfully moved production in-house from a contract
packager, with annual savings in excess of $500,000.
Suggested and implemented the purchase of the highest speed, most automated
condom foiling machine in the world, with annual projected labor savings of
$150,000 and twice the output of previous machines.
Suggested, justified, and implemented the conversion of Carter’s Little Pills packaging from an antiquated
vial format to a new blister card format, resulting in a $134,000 material and labor cost savings annually.
Implemented the development and production of Arrid Gel, and assisted in the negotiations for initial
production with a contract packager to successfully launch the product nationally. Subsequently lead a
team to bring the production in-house, within budget and on time.
Increased line speed for Arrid Aerosol production from 180 ppm to 360 ppm via line and equipment
upgrades.
Overall Engineering project responsibility for closing antiquated manufacturing plants in California, Puerto
Rico, and New Jersey, and relocating production. Maintained seamless product availability and completed
projects on time and on budget.
EDUCATION & TRAINING
BA in English from Ithaca College, Ithaca, NY. Past Company representative to the IOPP (Institute of
Pharmaceutical Packaging Professionals) and the NJPEC (NJ Packaging Exec Club).
SKILLS
MS Project, MS Excel, MS Power Point, MS Outlook, MS Word