Jeffery Downing

• Manages and mentors contract and FTE validation staff for the Upper Merion clinical sterile manufacturing site.
• Serves as local System Administrator for all validation equipment, including Kaye Validator 2000, Kaye AVS, Kaye Valprobes, and Kneat eValidation system.
• Owns the oversight of the change management program for the Upper Merion clinical sterile manufacturing site.
• Authors/revises the site validation master plan (SVMP) and any validation related Rationale documents.
• Provides validation expertise in support of changes to qualified equipment, new process equipment introductions, or facilities projects impacting validated systems.
• Serves as a technical resource and subject matter expert for sterile manufacturing processes, scale-up, utilities, mechanical systems, monitoring systems, and/or engineering disciplines.
• Performs Factory Acceptance Testing and Site Acceptance Testing as required.
• Collaborates with experts to integrate best practices into the program.
• Supports or leads interactions with internal/external auditors on matters pertinent to validation.
• Provides assistance to manufacturing operations as required.

GlaxoSmithKline

• Scheduled and executed annual and bi-annual revalidation efforts for Controlled Environmental Units, Autoclaves, Depyrogenation Tunnels, and Vial Washers.
• Authored and executed change control as needed.
• Maintained and updated building validation database to ensure compliance of all systems.
• Assisted Sterile Operations staff as needed throughout manufacturing processes.
• Developed and executed system life cycle documentation for new instrumentation and equipment, which included a sterile closed filling system, Microfluidizers, Homogenizers, Autoclaves, Hot Melt Extruders, Wet Bead Mills, Clean Utilities, etc.

Pelican BioThermal

• Authored and executed IQ/OQ/PQ protocols for new walk-in thermal conditioning rooms, walk-in refrigerators, and walk-in freezers at McNeil Consumer Products.
• Authored, developed, reviewed, executed and approved system documentation such as User Requirement Specifications, Critical Aspect Risk Assessments and Design Reviews for various equipment including Sonicators, Glatt Sieves, Kason Sifters, Bulk Tanks and CIP Modifications.
• Authored and executed change controls as needed.

McNeil Consumer Products (Lancaster)

• Conducted cleaning validation assessment and authored White Paper to reduce manual cleaning time of validated process.
• Contributed as a member of the Consent Decree Cleaning Validation team.
• Clean Equipment Hold Time team lead.

Stryker Orthobiologics

• Developed and executed validation plans for a new Double Piston Mixer, including Master Plan, SAT, SOP, IQ/OQ, Cleaning, and Sterilization (VHP and Autoclave).

Sanofi Pasteur

• Led the development and execution of Autoclave Liquid Load Study Cycle Development and PQ.

Merck & Co.

• Supported Solid Dosage Cleaning Validation for Fitz Mills, Cone Mills, Fluid Bed Bowl Inverters, Mixing Tanks, and Miscellaneous Parts.
• Developed Cleaning Validation Equipment Matrix.
• Led validation projects for pharmaceutical manufacturing facilities, ensuring regulatory compliance.
• Collaborated with cross-functional teams for successful validation of new products and processes.
• Developed and executed validation protocols, including IQ, OQ, and PQ, for equipment and processes.

• Developed and executed cleaning validation PQs for various equipment including Centrifuges, Harvest Tanks, Portable Tanks, Bioreactors, and Filter Skids.
• Project Manager for a team of numerous contractors.
• Validation lead for knowledge transfer and localized training of full-time employees related to the new manufacturing facility.

• Validated Manufacturing Equipment such as Cryo Vessel Tanks, Mobius Mixing Systems, and conducted various Mixing Studies.
• Laboratory Instrumentation and associated Computer Validation including AutoTitrators, Colorimeter, and MicroSEQ Microbial Identification System.
• Developed and executed the SIP revalidation program.

• Lead development of cleaning validation for Centrifuges, Harvest Tanks, Portable Tanks, Bioreactors, and Filter Skids.
• Developed and executed CIP/COP PQ protocols for Centrifuges, Harvest Tanks, Portable Tanks, Bioreactors, and Filter Skids.

• Developed and executed protocols for UV/IR Method Validation.

• Provided support for Process, Equipment, and Cleaning Validation in a Staff Augmentation role.
• Mentored junior level Consultants.

• Developed and executed CIP/COP OQ protocols for Centrifuges, Harvest Tanks, Portable Tanks, and Transfer Panels.
• Developed CIP/COP cycle using DeltaV for enhanced efficiency and productivity.

• Wrote and executed validation and computer validation protocols, final reports, traceability matrices, and associated documentation for laboratory instruments such as Waters HPLC (Empower 2), FT-IR OMNIC 8.1, and Hand Held NIR.

• Collected and analyzed data.
• Circulated associated protocols and reports for approval.
• Executed autoclave load study.

• Led validation activities for the expansion of a BSL-3 Biotech Facility.
• Commissioning and CIP/COP and SIP/SOP Cycle Development for Bioreactors, Filter Skids, Harvest Tanks, and Portable Kettles.
• Executed CIP/COP and SIP/SOP PQ and equipment IOQ for Bioreactors, Utility Stations, Transfer Panels, and Autoclaves.
• Re-qualified refrigerators, cold rooms, freezers, incubators, and autoclaves.
• Obtained certification as a confined space entrant/attendant.

• Wrote and executed Continuing and Initial Validation protocols for annual CIP and SIP studies, generating and evaluating related study data.
• Led validation for Recombivax and Pedvax suites, providing direct support to Alum and Buffer suites.
• Executed and designed developmental and equivalency studies as required for Change Requests, Corrective Actions, etc.
• Contributed as a member of the Sterilization Site Matter Expert team and specialized in Controlled Temperature Units.
• Executed and developed PQs for a variety of equipment such as Dry Heat Tunnels, Autoclaves, and Cold Rooms.

• Wrote and executed IQ/OQ/PQ/SOPs for various laboratory instruments such as TOC Analyzers, Plate Readers, Densitometers, HPLC, and Spectrophotometers.
• Wrote and executed Computer Validation test scripts for different laboratory instruments.

• Wrote and executed IQ/OQ/PQ/SR for laboratory instruments, maintaining ownership of systems throughout the life cycle.
• Equipment included: Incubators, Freezers, Refrigerators, Stability Cabinets, and Autoclaves.
• Instruments included: Centrifuges, Kaye Validator 2000 and ValProbes, Balances, Microscopes, Densitometers, Osmometers, TOC Analyzers, and Plate Readers.
• Conducted periodic reviews, risk assessments, and administrative tasks for all QC equipment and instrumentation.
• Oversaw and scheduled the work of a team consisting of four specialists.

• Wrote and executed life cycle documentation for laboratory instruments, manufacturing and packaging equipment, as well as utilities.
• Equipment and Utilities included: Incubators, Freezers, Refrigerators, DI Water system, and various mixers
• Instruments included: CellSpotter, CellTracks, Spectrophotometers, Centrifuges, TOC, Kaye Validator 2000, Particle Size Analyzer, and HPLC.
• Manufacturing and Packaging Equipment included Sample Chamber Assembly Machine and Liquid Filling Line.
• Provided oversight and direction to a team of up to three validation specialists.
• Collaborated on successfully bringing a diagnostic instrument from the research phase to its successful release.
• Successfully executed Process Validation for multiple aspects of the diagnostic instrument including onsite sample chamber manufacture and reagent manufacturing/filling.
• Led teams for projects including Cleaning Validation Implementation and Equipment/Instrument Validation.
• Conducted worst-case soil assessments, maximum carry-over evaluations, recovery studies, and identified rinse and swab areas across multiple construction materials.

• Developed, evaluated, and implemented PQs for new product process validations.
• Executed Process Validation protocols for solid dosage, liquid, cream, and ointment products.
• Wrote and assessed final validation summary reports for new and transferred products.
• Collaborated with team members to successfully transition products from the research/pilot phase through scale-up and eventual release.

• Developed customer-specific caulks and sealants through formulation and testing.
• Upgraded formulas to surpass current specifications.

• Instruments included: HPLC, Spectrophotometer, Pulse NMR, and Lovibond Tintometer.
• Tests included: Dextrose Equivalence, Microbiological Testing, and Titrations.