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Jose Candelario
Summary of Qualifications
Manufacturing supervisor with Bachelor Network Technology and Applications Development (BDNTAD). Also
possess an Associate Degree in Electronic Technician. Professional with twelve years of experience in the
Pharmaceutical Industry. Wide knowledge of aseptic techniques and processes for parenteral and lyophilized
products. Vast experience in bulk (formulation), validation, vial washer machine operation and equipment -
component preparation area (including stoppers processing machines). Experience in plant startup and closing
activities. Project Management and Yellow Belt Certification. Experience in Kronos System. Subject Matter
Expert (SME) in several areas of the department, make certain processing decisions to ensure products are
manufactured efficiently and of high quality standards in accordance with all safety, GMP’s, SOP’s and batch
record requirements. Leader, responsible, honest, organized, ability to cross function and work in multiple
projects simultaneously, with minimum supervision. Wide experience as qualified trainer. Able to execute
operations, manufacturing processes electronically. Some problem solving skills (problem identification, basic
analysis, application of corrective action). Ability on install and configure computer systems and mechanical
ability on preventive maintenance. Interpersonal skills that is compatible in an environment of teamwork.
Broad experience in Microsoft Office (Word, Excel, PowerPoint, Project) and Visio. Basic knowledge in English.
Excellent written/ oral communication in Spanish.
Job Type: Permanent/ Contract
Work Schedule: Full Time
Professional Experience
Employer Name: San Jorge Children’s Hospital Dates: 04/15-06/15
San Juan, Puerto Rico Salary: College Practice
Hours per Week: 40
Supervisor: Denis Ayala (939) 717-8230 (Permission to contact)
Title: Information System Technician
∑ Supported and assisted hospital operative system
∑ Knowledge in cloud computing and server
∑ Direct collaboration in the implementation of electronic medical record, MEDHOST
∑ Experienced with Program codes such as; HTML, Java, Java Script, C++ and Visual Basic
∑ Wide knowledge on data base (SQL), programing and how to use different programs for the
creation of applications
∑ Active participation on the installation of Clinic System Applications (GV, CV, EDIS, PACS), on
VPN access, on Hardware maintenance troubleshooting, drug carts configuration, documentation
and updates
∑ Created operative system image in conjunction with the installation and configuration of printers,
laptops and desktops
Accomplishments
∑ Successful implementation of electronic medical record, being San Jorge Children’s Hospital the
first hospital at Puerto Rico operating fully electronic
∑ Time reduction of 50% in responds technical support needs
(787) 547-6538
jose.candelario78@gmail.com
Jose Candelario
Employer Name: Pfizer Inc. LLC, Carolina, Puerto Rico Dates: 12/11 - 12/12
Hours per Week: 40
Supervisor: Jenise Neris (787) 426-3112 (Permission to contact)
Title: Manufacturing Supervisor
∑ Supervised manufacturing operators on first and second shift at Equipment - Component
Preparation Area
∑ Collected the required data for the corresponding event evaluation.
∑ Provided guidance and support to manufacturing events
∑ Created and revised standard operating procedures (SOPs)
∑ Prepared personnel schedules
∑ Maintained cost effective operation
∑ Generated change control quality system
∑ Completed safety incident reports
∑ Coordinated Equipment Preparation Area tasks in order to support manufacturing operations
∑ Qualified trainer, mentor manufacturing operators. Provides technical support and guidance in
resolving technical problems and areas of documentation (format and content) required to
achieve a high level of knowledge transfer
∑ Made presentations to organizational staff
∑ Assisted meetings with organizational staff to discuss issues pertaining to manufacturing
operations
∑ Assisted FDA, Medicines and Healthcare Products Regulatory Agency (MHRA), ANVISA and
Corporate Inspections, among others.
Accomplishments
∑ Achieved no critical observations on MCA, FDA, MHRA, ANVISA and internal audits, among
others
∑ Attained an outstanding business metrics results, reducing investigations on Equipment
Preparation Area related to job performance (human error) by 100% for a period of two (2)
consecutive years
∑ Increased productivity and cost savings
∑ Contributed to business unit knowledge of compliance
∑ Collaborated to an on time pharmaceutical plant closure that comply with the established
regulatory and compliance requirements
Employer Name: Wyeth, Carolina, Puerto Rico Dates: 03/00 - 12/11
Hours per Week: 40
Supervisor: Olga Medina (787) 370-1792 (Permission to contact)
Title: Manufacturing Technician II
∑ Provide support to formulation area; approval of QS and filter integrity tests
∑ Vial washer machine, autoclaves (Fedegari, Finnaqua y Gettinge), “Cabinet Washer”, ICOS
Oven and Stopper processing machines (ICOS, Huber) operation
∑ Directed activities of eleven operators at Equipment Preparation Area
∑ Active participation in decision making; perform (some may be non-routine) tasks that occasionally may
require some judgment and interpretation to successfully manufacture the product
∑ Prioritize the order of work tasks to meet schedule attainment
∑ Train other manufacturing operators in process equipment and procedures
∑ Periodically, encounter unexpected production problems as well as process deviations. Evaluates the
situation and reports it to immediate supervisor, operational excellence specialist or quality specialist to
resolve the issue
Jose Candelario
∑ Revise procedures and documentation forms
∑ Works in a team environment to accomplish individual/ team goals in the manufacture of products
∑ Prepared personnel schedules
∑ Generate event notification reports
∑ Supported investigation reports
∑ Conducted safety incidents reports
∑ Prepared shift reports
∑ Active participation on media fills with satisfactory results
∑ Conducted preventive maintenance to Autoclave and Stoppers Processing Machines
∑ Handled and transported controlled substances, hazardous and non-hazardous wastes
∑ Verification and approval of sterilization cycle’s graphics
∑ Executed Validation and Qualification protocols
Accomplishments
∑ Developed and implemented time-saving techniques, recommends/ proposes cost reduction, quality,
process, and safety improvements
∑ Make adjustments to minimize product loss, maximize output and ensure product quality
∑ Contributed to the validation of new disinfectant solutions and perform a procedure for the
implementation
∑ Implementation of Autoclaves Cycles Improvements, reducing operational costs and increase
productivity
∑ Successful participation on media fill runs
∑ Document simplification project completion
∑ Reduced investigations on Equipment Preparation Area related to job performance (human error)
by 100% for a period of two (2) consecutive years
Employer Name: Masso, Carolina, Puerto Rico Dates: 01/97 - 02/00
Hours per Week: 40
Supervisor: Angel Caratini (Retired)
Title: Supervisor
∑ Customer service
∑ Prepared work schedule
∑ Loss control
∑ Clerical work
∑ Supervise forty-two employees
∑ Attend merchandise delivery
∑ Coordinate the materials dispatch
∑ Performed inventory
∑ Attend employees payroll
∑ Front-end duties
∑ Recruit personnel
∑ Request merchandise and material needed
Jose Candelario
Education
National University College, Rio Grande, Puerto Rico
Bachelor Network Technology and Applications Development (BDNTAD), 2015. GPA 4.00
Polytechnic University, Hato Rey, Puerto Rico
Civil Engineering - 12 Credits at Sub graduate Level, 2005.
San Juan University College, San Juan, Puerto Rico
Associate Degree Electronic Technician, 1998.
Trainings/ Certifications
∑ Gowning Profile Qualification, 2012
∑ Core Skills for Managing Projects, 2012
∑ Manufacturing Electronic System (MES), 2012
∑ System Application and Products (SAP) Database, 2011
∑ Training Information Management System (TIMS), 2011
∑ Yellow Belt - Six Sigma Certification, 2011
∑ BMS Data Historian, 2011
∑ Risk Assessment, 2010
∑ Aseptic Techniques, 2009
∑ GxPharma, 2009
∑ Process Knowledge Robustness, 2009
∑ Aseptic Processing of Parenteral Products, 2002
∑ Good Manufacturing Practices for Parenteral Drugs, 2002
∑ USPS Boating Course, 2002
∑ ISOTrain, 2001

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CV-Jose - 2015

  • 1. Jose Candelario Summary of Qualifications Manufacturing supervisor with Bachelor Network Technology and Applications Development (BDNTAD). Also possess an Associate Degree in Electronic Technician. Professional with twelve years of experience in the Pharmaceutical Industry. Wide knowledge of aseptic techniques and processes for parenteral and lyophilized products. Vast experience in bulk (formulation), validation, vial washer machine operation and equipment - component preparation area (including stoppers processing machines). Experience in plant startup and closing activities. Project Management and Yellow Belt Certification. Experience in Kronos System. Subject Matter Expert (SME) in several areas of the department, make certain processing decisions to ensure products are manufactured efficiently and of high quality standards in accordance with all safety, GMP’s, SOP’s and batch record requirements. Leader, responsible, honest, organized, ability to cross function and work in multiple projects simultaneously, with minimum supervision. Wide experience as qualified trainer. Able to execute operations, manufacturing processes electronically. Some problem solving skills (problem identification, basic analysis, application of corrective action). Ability on install and configure computer systems and mechanical ability on preventive maintenance. Interpersonal skills that is compatible in an environment of teamwork. Broad experience in Microsoft Office (Word, Excel, PowerPoint, Project) and Visio. Basic knowledge in English. Excellent written/ oral communication in Spanish. Job Type: Permanent/ Contract Work Schedule: Full Time Professional Experience Employer Name: San Jorge Children’s Hospital Dates: 04/15-06/15 San Juan, Puerto Rico Salary: College Practice Hours per Week: 40 Supervisor: Denis Ayala (939) 717-8230 (Permission to contact) Title: Information System Technician ∑ Supported and assisted hospital operative system ∑ Knowledge in cloud computing and server ∑ Direct collaboration in the implementation of electronic medical record, MEDHOST ∑ Experienced with Program codes such as; HTML, Java, Java Script, C++ and Visual Basic ∑ Wide knowledge on data base (SQL), programing and how to use different programs for the creation of applications ∑ Active participation on the installation of Clinic System Applications (GV, CV, EDIS, PACS), on VPN access, on Hardware maintenance troubleshooting, drug carts configuration, documentation and updates ∑ Created operative system image in conjunction with the installation and configuration of printers, laptops and desktops Accomplishments ∑ Successful implementation of electronic medical record, being San Jorge Children’s Hospital the first hospital at Puerto Rico operating fully electronic ∑ Time reduction of 50% in responds technical support needs (787) 547-6538 jose.candelario78@gmail.com
  • 2. Jose Candelario Employer Name: Pfizer Inc. LLC, Carolina, Puerto Rico Dates: 12/11 - 12/12 Hours per Week: 40 Supervisor: Jenise Neris (787) 426-3112 (Permission to contact) Title: Manufacturing Supervisor ∑ Supervised manufacturing operators on first and second shift at Equipment - Component Preparation Area ∑ Collected the required data for the corresponding event evaluation. ∑ Provided guidance and support to manufacturing events ∑ Created and revised standard operating procedures (SOPs) ∑ Prepared personnel schedules ∑ Maintained cost effective operation ∑ Generated change control quality system ∑ Completed safety incident reports ∑ Coordinated Equipment Preparation Area tasks in order to support manufacturing operations ∑ Qualified trainer, mentor manufacturing operators. Provides technical support and guidance in resolving technical problems and areas of documentation (format and content) required to achieve a high level of knowledge transfer ∑ Made presentations to organizational staff ∑ Assisted meetings with organizational staff to discuss issues pertaining to manufacturing operations ∑ Assisted FDA, Medicines and Healthcare Products Regulatory Agency (MHRA), ANVISA and Corporate Inspections, among others. Accomplishments ∑ Achieved no critical observations on MCA, FDA, MHRA, ANVISA and internal audits, among others ∑ Attained an outstanding business metrics results, reducing investigations on Equipment Preparation Area related to job performance (human error) by 100% for a period of two (2) consecutive years ∑ Increased productivity and cost savings ∑ Contributed to business unit knowledge of compliance ∑ Collaborated to an on time pharmaceutical plant closure that comply with the established regulatory and compliance requirements Employer Name: Wyeth, Carolina, Puerto Rico Dates: 03/00 - 12/11 Hours per Week: 40 Supervisor: Olga Medina (787) 370-1792 (Permission to contact) Title: Manufacturing Technician II ∑ Provide support to formulation area; approval of QS and filter integrity tests ∑ Vial washer machine, autoclaves (Fedegari, Finnaqua y Gettinge), “Cabinet Washer”, ICOS Oven and Stopper processing machines (ICOS, Huber) operation ∑ Directed activities of eleven operators at Equipment Preparation Area ∑ Active participation in decision making; perform (some may be non-routine) tasks that occasionally may require some judgment and interpretation to successfully manufacture the product ∑ Prioritize the order of work tasks to meet schedule attainment ∑ Train other manufacturing operators in process equipment and procedures ∑ Periodically, encounter unexpected production problems as well as process deviations. Evaluates the situation and reports it to immediate supervisor, operational excellence specialist or quality specialist to resolve the issue
  • 3. Jose Candelario ∑ Revise procedures and documentation forms ∑ Works in a team environment to accomplish individual/ team goals in the manufacture of products ∑ Prepared personnel schedules ∑ Generate event notification reports ∑ Supported investigation reports ∑ Conducted safety incidents reports ∑ Prepared shift reports ∑ Active participation on media fills with satisfactory results ∑ Conducted preventive maintenance to Autoclave and Stoppers Processing Machines ∑ Handled and transported controlled substances, hazardous and non-hazardous wastes ∑ Verification and approval of sterilization cycle’s graphics ∑ Executed Validation and Qualification protocols Accomplishments ∑ Developed and implemented time-saving techniques, recommends/ proposes cost reduction, quality, process, and safety improvements ∑ Make adjustments to minimize product loss, maximize output and ensure product quality ∑ Contributed to the validation of new disinfectant solutions and perform a procedure for the implementation ∑ Implementation of Autoclaves Cycles Improvements, reducing operational costs and increase productivity ∑ Successful participation on media fill runs ∑ Document simplification project completion ∑ Reduced investigations on Equipment Preparation Area related to job performance (human error) by 100% for a period of two (2) consecutive years Employer Name: Masso, Carolina, Puerto Rico Dates: 01/97 - 02/00 Hours per Week: 40 Supervisor: Angel Caratini (Retired) Title: Supervisor ∑ Customer service ∑ Prepared work schedule ∑ Loss control ∑ Clerical work ∑ Supervise forty-two employees ∑ Attend merchandise delivery ∑ Coordinate the materials dispatch ∑ Performed inventory ∑ Attend employees payroll ∑ Front-end duties ∑ Recruit personnel ∑ Request merchandise and material needed
  • 4. Jose Candelario Education National University College, Rio Grande, Puerto Rico Bachelor Network Technology and Applications Development (BDNTAD), 2015. GPA 4.00 Polytechnic University, Hato Rey, Puerto Rico Civil Engineering - 12 Credits at Sub graduate Level, 2005. San Juan University College, San Juan, Puerto Rico Associate Degree Electronic Technician, 1998. Trainings/ Certifications ∑ Gowning Profile Qualification, 2012 ∑ Core Skills for Managing Projects, 2012 ∑ Manufacturing Electronic System (MES), 2012 ∑ System Application and Products (SAP) Database, 2011 ∑ Training Information Management System (TIMS), 2011 ∑ Yellow Belt - Six Sigma Certification, 2011 ∑ BMS Data Historian, 2011 ∑ Risk Assessment, 2010 ∑ Aseptic Techniques, 2009 ∑ GxPharma, 2009 ∑ Process Knowledge Robustness, 2009 ∑ Aseptic Processing of Parenteral Products, 2002 ∑ Good Manufacturing Practices for Parenteral Drugs, 2002 ∑ USPS Boating Course, 2002 ∑ ISOTrain, 2001