Michael J. Molloy, P.E.
Mr. Michael Molloy is a professional engineer with over 20 years of experience in biotech and pharmaceutical facility, equipment, design and qualification. Mr. Molloy has managed manufacturing operations and engineering at contract parenteral drug manufacturing facilities
specializing in the formulation, filling, lyophilization, and finishing of aseptic drug product. In addition, he has worked as a consultant and engineer in various aspects of design, fabrication, and validation of GMP facilities and equipment.
Process Design and Equipment
Water for Injection (WFI); Purified Water (PW); Pure Steam (PS); Clean-In-Place (CIP); Steam-In-Place (SIP); Process Waste; Clean Rooms; RABS; HVAC; Product Delivery and Compounding; Vial / Bottle Filling and Sealing; Packaging and Labeling;Decontamination Systems; Fermentation; Lyophilization; Autoclaves; Spray Drying; GMP Instrumentation; Process Control Systems; SCADA; BMS
Process and Instrumentation Diagrams (P&IDs); 3D Modeling (Solidworks / Revit); User Requirement Specifications; Project Management; Commissioning; FAT / SAT; Validation (IQ/OQ/PQ); SOPs; Legacy Equipment / Facility Design and Documentation; Maintenance Programs; Calibration Programs; Process Design Calculations
Installation of Equipment; Capital Management; NIST Calibration; 3rd Party QC; ASME BPE Certified Piping; Process Technical Transfer; Cycle Development; Computer Validation