Patrick O'Connell Email & Phone Number

Acton, MA, US

Fort Collins, CO, US

Development, execution, review, and coordination of activities including commissioning, qualification and validation of facilities, utilities, manufacturing process equipment and cleaning validation for product manufacturing facilities. Acts as lead engineer to provide support to, and mentoring of, other engineers.

Dublin, IE

Responsible for validation / qualification of plant automation / SCADA systems associated with equipment / systems / utilities / facilities, meeting FDA and corporate guidelines. ·Responsible for preparation, review and execution of plant automation / SCADA qualification protocols. Responsible for preparation and review of qualification reports and other.

Work closely with validation change owners from Engineering, Manufacturing and IT to plan and draft validation documents and assure proper execution, documentation of test results. Responsible for reviewing, executing and approving validation documents. Responsible for ensuring validation documentation is in compliance with Plant and Corporate policies and.

Validation Engineer-Heavily involved in implementing quality policies used to meet FDA standards. Responsible for drafting and executing Software-, Installation-, and Operational Qualification plans and protocols and finalizing Qualification reports for custom built automated systems for pharmaceutical manufacturing, medical device, and insulin delivery.

Raleigh, North Carolina, US

Performed execution of OQ and PQ of Steris autoclave and Lancer GlasswasherPerformed execution of Facility QualificationPerformed execution of HVAC IQPerformed execution of Building Management System (BMS) IQ

• (Mayne Pharma, Boulder CO)
• Drafted and executed Commissioning Protocols and IQ/OQ (Installation/Operational Qualification) in an Active Pharmaceutical Ingredient expansion plant: Bioreactors, Gas systems, HVAC, Cryogenic chiller, Mixers, Product.
• Drafted, executed, and finalized validation reports for IQ/OQ/PQ (Performance Qualification) protocols for installation of new Media Transfer line.
• Incorporated Intellution MMI and supervisory control and data acquisition (SCADA) controls and interface into testing. (Amgen, Longmont CO)
• Drafted, executed, and finalized validation reports for IQ/OQ of controlled temperature units used for cell cultures in client laboratories. (Amgen, Longmont CO)
• Drafted, executed, and finalized validation reports for IQ/PQ of Deionized Water expansion in client laboratories. (Insmed Therapeutic Proteins, Boulder CO)

Pomona, CA, US

• (Elan Pharmaceuticals, Gainesville GA)
• Drafted/executed IQ/OQ of process equipment for a solid dosage pharmaceutical manufacturer: Vector GX 40 Granulator, Glatt fluidizers, Laboratory scales, Heat Shrink tunnel, Mixers.(Introgen, Houston, TX)
• Authored detailed system definitions and IQ in preparation for revalidation of pharmaceutical manufacturing facility: Clean Steam Generator, Compressed Gases (Medical), and Compressed Air systems.(Watson Labs, Salt.
• Authored and executed IQ/OQ/PQ, Functional Requirement Specifications and Traceability Matrix for multifunction Liquid Reservoir System Transdermal Device Fabricating and Pouching Machine used for the production of.

• Authored and prepared all relevant protocols and reports for validation of cryogenic storage units.
• Performed Installation/Operation Qualification of 160+ portable refrigeration units utilized in Cold Chain Management of temperature sensitive materials, following FDA guidelines and cGMP's.
• Developed readiness tracking report for 160+ on-hand portable refrigeration units to enhance deployment capability.
• Performed validation of central temperature monitoring system following 21 CFR 11 requirements.
• Operated/Monitored central temperature monitoring system for temperature sensitive assets.
• Authored training summary for temperature monitoring system to be used in other repositories.