Patrick Bunker Email & Phone Number

Toronto, On, Ca

Paris, France, Fr

Paris, France, Fr

Paris, France, Fr

Paris, France, Fr

San Ramon, California, Us

Process Engineer for multi-product orphan drug manufacturing processes • Managed proposal, bid assessment, design approval, acceptance testing for several new skids (Tangential Flow Filtration, Chromatography)• Spec’ed and sourced multiple pieces of equipment, including blast freezer, parts washers, etc.• Troubleshot fermentation process through analysis of heat load and mixing parametersProject lead for purification equipment cleaning and process validations for new product in existing multi-product bio-manufacturing facility• Scheduled engineering and validation runs; liaised with Manufacturing, Quality and Engineering• Cleaning validation for chromatography and filtration skids, vessels, and other small equipment, both existing and new equipment• Process validation for mixing of in-process fluids, product hold times, freeze and thaw cyclesNew Aseptic Filling Facility for small-molecule pharmaceuticals• New HVAC system commissioned and qualified• Environmental monitoring program validated and implemented• Auxiliary equipment such as laminar flow hoods and compounding tanks qualified• User specifications and validation master plan created for subsequent renovation

Paris, France, Fr

Managed $7M project with critical deadlines to address FDA observations – completed on schedule• Developed and qualified cycle for Vaporized Hydrogen Peroxide disinfection system• Sourced and qualified biosafety cabinets to improve containment of live virus process• Reduced nuisance differential pressure alarms by over 60% through investigation and rebalancing of BioSafety Level 2 area HVAC• Managed schedules and budgets for over a dozen capital projects simultaneouslyCommissioned chilled water utility conversion to reduce domestic water use by over 2.5 Million gallons• Design, manufacture and qualification of various biotech equipment including a TFF skid, clean utility upgrades, room classification upgrades, CIP solution distribution system• Improved reliability of continuous effluent decontamination system for a classified virus production facility by troubleshooting and implementing PLC and physical process changes• Key engineering resource for site-wide assessment of effluent containment gaps, provided short- and long-term solutionsBiosafety Officer, JHSC liaison and HSE relay for department, ensuring safety protocols and training were followed by working with colleagues

Paris, France, Fr

-Commissioned and validated several CIP systems as well as other capital projects-Lead Investigator for root cause analysis of issues arising during normal production-Initiated yield improvement studies to increase efficiency of protein purification

L-1160 Luxembourg, Lu

-Assisted with environmental task management for major capital projects-Reviewed environmental processes and equipment-Completed applications for governmental approvals for environmental projects

Racine, Wi, Us

-Spearheaded process line optimizations reducing waste, downtime and improving quality yielding a cost savings of over $300,000/year in conjunction with QA and Operation Specialist-Organized and managed several short-term projects independently from conception to implementation-Trained dozens of plant employees on new software implementation and process equipment

Mba, Business Administration And Management, General

Basc, Chemical Engineering