Paul R. Calderwood

**** *. ***** **.

Wheaton, IL 60187

C 630-***-****

adz0b3@r.postjobfree.com

Summary of Qualifications

Results-oriented Senior Quality Validation Engineer with extensive experience in pharmaceutical, medical device and contract manufacturing facilities. Proficient in developing validation protocols, operational procedures and maintenance documentation. Skilled in equipment troubleshooting, serialization validation and temperature mapping. Strong team player and mentor with a proven track record of delivering high quality results.

Skills

Production Equipment IQ/OQ/PQ

Microsoft Office Suite (Work, Excel)

Facility/Utilities IQ/OQ/PQ

Computer System Validation

cGMP Compliance

Adaptability

Serialization Validation

Team Oriented

Equipment Troubleshooting

Mentoring

Risk Assessment

Time Management

Work Experience

Takeda Phamaceuticals via Automated Systems Inc.

Validation Consultant (July 2023 – Present)

Write, perform and summarize Installation, Operational and Performance Qualification protocols for incubators and serialized packaging equipment.

Abbott Core Diagnostics via Automated Systems Inc.

Quality Validation Engineer (November 2022 – June 2023)

Write, perform and summarize Installation, Operational and Performance Qualification protocols for temperature mapping of warehouse area and temperature controlled environments.

Woodstock Sterile Solutions via Automated Systems Inc.

Quality Validation Engineer (January 2022 – November 2022)

Develop and execute Installation, Operational and Performance Qualification protocols for serialization equipment for transitioning into local systems. Participate in Installation, Operational and Performance qualification of an electronic validation execution system. Peer reviewing of User Acceptance Testing of JDE system.

Fresenius Kabi via Automated Systems Inc.

Senior Validation Contractor (October 2020 – January 2022)

Write Installation and Operation Qualification protocols for new filling system lines, including a vial washer, depyrogenation tunnel, filling machine, an isolator and capping machine. Develop Installation, Operational and Performance Qualification, User Requirement Specifications and Risk Assessment protocols for an Automated Storage and Retrieval System. Perform Utility System (Nitrogen, WFI) IOQ execution. Utilized Documentum, Monday.com software.

Catalent Pharma Solutions

Senior Validation Engineer (January 2019 – October 2020)

Manage Serialization project for Validation planning with other departments to complete the writing, execution and summarizing of the qualifications and recipes. Plan process validation for new products. Review and approve annual product reviews, media fills, validation master plans, Part 11 Risk Assessment and continuous process verification plans.

Catalent Pharma Solutions via Automated Systems Inc.

Validation Contractor (August 2017 – January 2019)

Qualify Serialization Equipment for initial production use. Perform Revalidation Assessment for Utility Systems (Water for Injection, Clean Steam, Nitrogen) and Production Equipment (Tip Cap Assembly Machine),. Performed Equipment validation for system changes. Utilized Trackwise, Documentum, and JD Edwards software.

CSL Behring via Automated Systems Inc.

Senior Validation Engineer Consultant (October 2016 – August 2017)

Conduct Commissioning and Installation/Operational activities which include, P&ID review, Component, Instrument, MOC and Finish, Vendor Documentation, Utilities and SOP verification, Temperature mapping using Kaye data loggers, Performed Riboflavin and Colorimetric testing, reviewed documents and performed investigations. Utilized SAP software and PI Coresight Plant Historian software.

Sunstar Americas Inc.

Validation Consultant (November 2013 – June 2016)

Review validation documentation for compliance with FDA and ISO standards. Created IQ/OQ/PQ protocols for production equipment. Revalidated equipment/systems. Assisted in evaluating the risk assessment of wet chemistry expansion.

Northfield Laboratories Inc., Mt. Prospect, IL

Validation Supervisor/Senior Validation Specialist (2000 – 2005)

Developed and managed Facility Validation Master Plan, including Sub-plans such as: Equipment/Facility, Process, Analytical Method, Microbiological Method, Computer and Cleaning Master Plans.

Reviewed and provided guidance in the development of GAMP documents.

Coordinated with plant personnel and consultants, developed, executed and summarized validation protocols, including IQ/OQ/PQ for process equipment (including process control and computer/software systems), support equipment (clean steam autoclaves, incubators, integrity testers), Utilities (WFI, DI (Purified) water, Clean Steam, Plant Steam, Compressed Air, Process Gases, HVAC) and Analytical Equipment.

Developed and performed facility Validation Training program.

Equipment Engineer (1997 – 2000)

Assisted in the facility Scale up project (6,000 units/yr facility to 10,000 units/yr) in performing the following: Valve material determination, weld inspection, initial utility validation (WFI, Clean Steam, Process Gases, HVAC, Automated Processing System), verified piping and instrumentation drawing and loop drawings.

Directed the development of a new bag sealer and purchase new filler.

Production Team Leader (1995-1997)

Developed and directed the initial validation of critical systems (WFI, Clean Steam, Clean Steam Autoclave, Environmental chambers, Product Storage equipment).

Assisted in troubleshooting process and facility equipment.

Production Team (1990 – 1995)

Performed Process Development and developed Master Batch Records.

Developed the Facility Blood Inventory System.

Education

University of Cincinnati, College of Arts and Sciences

Bachelor of Science in Biology

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