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Kent D. Waldron
Computer System, Manufacturing Equipment, and Process Validation Engineer and Manager
201-206-9094 kentwaldron75@gmail.com
MISSION STATEMENT/OBJECTIVE
To function as a Computer Systemand Process Validation Specialist for a manufacturer of medical devices or
software within the Life Sciences or Chemical Manufacturing market. Personal objective is to apply varied talents,
drive, ambition, and dedication to providing clients with a quality product delivered in a timely manner.
Considered an articulate, analytical, motivated individual who seeks and accepts challenges and expends whatever
time and effort is necessary to exceed expectations. Extensive and varied experience in the areas of laboratory
operations and project management, computer systemvalidation, scientific data production, management, control
and reporting. Areas of expertise include cost reduction, problemsolving, and productivity improvement. Work well
under pressure, and consistently meet deadlines while handling multiple priorities.
Proficient with Minitab statistical software and statistical analysis as applied to Process Engineering.
PROFESSIONAL EXPERIENCE
Stryker Orthopaedics
Mahwah, NJ Senior Staff Validation Engineer 10/2016 – Present
Responsible for maintaining, improving, and promoting the validation process across all North American sites.
Mentor, train, and certify engineers in validation practices.
 Corporate Validation Team – Divisional Process Owner
 Represent Orthopaedics Division in all Corporate Validation Initiatives.
 Function as Subject Matter Expert for Corporate Computer SystemValidation Team.
 Leader of Corporate Statistical Analysis and Methods Team.
 Attend various international Validation Summit meetings.
 Serve as Reconstructive Division representative on Corporate Inspection Process Improvement Team.
 Management of Validation Team
 Responsible for daily management of validation assignments and logistics for a global shared services
teamthat provides validation services to all North American facilities.
 Create and report metrics to Management.
Stryker Orthopaedics
Mahwah, NJ Senior Validation Engineer/Quality Engineer 3/2006 – 10/2016
Responsible for validation, verification, and performance of medical device manufacturing equipment and integrated
software systems.
 Create and execute equipment qualification and manufacturing process protocols.
 Interact with operations/manufacturing to ensure all manufacturing equipment remains in a controlled and
validated state.
Provide Quality Engineering support to Operations manufacturing departments.
 Conduct Quality Audits of manufacturing processes.
 Review and approve all quality-related manufacturing documents e.g. inspection reports, inspection guide
sheet content, gage approvals and qualification forms.
 Maintain quarantined product and manage rework quality documentation.
 Track Monthly Improvement metrics and Quality Acceptance Tests
 Document and investigate non-conformances and manage corrective/preventative actions.
Stryker Orthopaedics
Mahwah, NJ Computer System Validation Engineer/Analyst 3/2003 – 3/2006
Responsible for the creation, execution, and maintenance of documents, procedures, and protocols to ensure the
validation, verification, and performance of medical device manufacturing software.
 Manage all phases, including personnel and logistics, of Computer SystemValidation projects.

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 Interact with vendors and IT personnel to develop validation approach and protocols for customdesigned
software systems.
 Interact with operations/manufacturing to ensure compliance of all computerized equipment.
 Manage validation projects and central inventory/tracking systems for equipment and related validation
documentation.
 Develop and manage implementation of compliance gap remediation tasks for all computerized
manufacturing systems.
Cetan Technologies, Inc.
Wilmington, North Carolina Senior Scientist/Project Manager - Computer System Validation 10/2000
through 3/2003
Responsible for the creation, execution, and maintenance of documents, procedures, and protocols to ensure the
validation, verification, and performance software products and computer systems being implemented at major
pharmaceutical, bio-technology, and industrial chemical facilities.
 Manage computer systemvalidation projects. Schedule resources, testing personnel, and develop timelines
and milestones to meet client requirements in a timely and cost-effective manner.
 Prepare systemand functional requirement documents, test scripts, test plans, and summary reports.
 Execute and manage on-site validation projects.
 Participate in client start-up, status, and project summary meetings.
 Conduct audits of facilities for CFR Part 11 compliance.
 Conduct training seminars on computer systemvalidation and CFR Part 11 compliance.
Astrix Software Technology, Inc.
Edison, NewJersey Quality Assurance/Product Testing Mgr. 11/1999 – 10/2000
Responsible for the development, implementation, and maintenance of documents, procedures, and tracking systems
to ensure the development, delivery, and continued support of high quality software products.
 Managed testing personnel, version control, and schedule and approve build release. Prepared test scripts,
test plans, and validation scripts. Developed and implemented quality control testing and document
control standards and procedures.
Astrix Software Technology, Inc.
Edison, NewJersey Project Manager 1998 – 10/1999
Functioned as in-house Database Administrator and Systems Consultant for Bayer Corporation’s Agricultural
Research Park located in Stilwell, KS from1999-2000.
 Maintained & updated the Residue Chemistry Field Research database - generated using Astrixsoftware.
 Served as the Field Coordinator and Project Manager for the crop pesticide residue program.
 Required communicating electronic protocols and GLP requirements to field personnel.
 Provided technical support of field technicians.
 Coordinated the receiving and archiving of field data updates for over 500 trials per growing season.
 Increased throughput by a factor of three utilizing guidance and management skills. (Resulted in the offer of
a lucrative, high level position)
CORELaboratories, Inc.
Edison, NewJersey Laboratory General Manager 1997 - 1998
(PACEInc. prior to 12/22/95 andETC Corp. prior to 8/4/94)
Responsible for overseeing facility operations, sales, and marketing.
 Coordinated and managed all aspects of an environmental testing laboratory, including human resources,
personnel, payables, receivables, contract negotiation, and daily operations.
 Reported to corporate headquarters on invoicing, accounting, and profit and loss through weekly and
monthly production and financial reports. Interacted with clients and government agencies.
 Managed 90 direct-report people on a day-to-day basis along with interfacing with sub-contractors, clients,
and sales force.
CORELaboratories, Inc.
Edison, NewJersey Technical Project Manager 1995 - 1997
Responsibilities included implementation of scope and tracking project details as defined by the client, initiating and
reviewing Quality Assurance and Quality Control requirements as per project specifications, scheduling and
organizing project details, and daily review and tracking of projects and programs.
 Served as liaison between clients and laboratory operations.
 Interacted with clients, field, sales, and laboratory personnel to ensure timely completion of projects.

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 Assigned to work with high profile energy corporations – Exxon, Hess, E.I. DuPont, etc.
CORELaboratories, Inc.
Edison, NewJersey Wet Chemistry Manager 1993 - 1995
Responsible for coordinating workflow and personnel. Duties included production scheduling, method development
and data review.
 Improved efficiency by consolidating analysis types. Implemented methods in-house to reduce sub-
contract costs by 75%.
CORELaboratories, Inc.
Edison, NewJersey Organic Extraction Supervisor 1987 - 1993
Organized and scheduled sample preparation work and personnel.
 Participated in client, government, and internal Quality Assurance audits.
 Provided training and supervision to laboratory technical staff on use of prescribed USEPA methods and
protocols.
 Managed work group that was the highest revenue generator by implementing cycle time reduction
programs.
Seton Hall University
South Orange, NewJersey 1984 - 1987
 Graduate Research Assistant (1984 – 1987)
 Conducted independent research utilizing recombinant DNA technology. Techniques included gel
electrophoresis, restriction enzymes, and various DNA isolation and purification methods on viral,
bacterial, and fungal organisms.
 Adjunct Professor (1986 – 1987)
 Lectured and conducted laboratories in microbial genetics.
 Teaching Assistant (1984 – 1986)
 Taught various undergraduate pre-medical laboratories and lectures.
AWARDS
Global QA/RA awardfor Corporate Sustainability (2016)- Awarded for implementing and maintaining Corporate
Validation programand standards across all North American manufacturing facilities
Global Operations andQuality Awardfor Collaboration (2015) – Awarded for managing teamof Validation and
Operations Engineers that redesigned two production cells to increase throughput, quality, and cost savings.
Global Operations andQuality Awardfor Innovation (2014) – Awarded for planning, writing protocols, and managing
all phases of customized automation line and associated software systems.
Global Operations andQuality Awardfor Customer Service (2013) – Awarded for managing Validation Teamthat
exceeded all customer requirements and achieved 100% first time yield and 100% on time delivery.
Individual Achievement Awards – Received numerous quarterly bonus awards for outstanding customer service
providing validation support and management.
PROFESSIONAL AFFILIATIONS
Member Institute of Validation Technology
Member International Society of Pharmaceutical Engineers
EDUCATION/CERTIFICATIONS
Seton Hall University – M.S. Microbiology – (awarded full research/teaching scholarship degree pending) 1987
Kutztown University of PA – B.S. Biology – (received “Outstanding Biologist” Award) 1984

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Various Validation, GAMP, FDA Compliance, and Manufacturing Compliance Courses 2000-Present
Various Mgmt., Production Control, & Quality Assurance Courses 1987-98
SystemTesting and QA Techniques (Advanced Information Technologies) 2001