Ollie – Validation Engineer
- Instrumentation Control System Development/Implementation: Process Control, PLC Programming, Water System, HVAC, Clean Room, Analytical/Process Instrumentation, Packaging Equipment, Waste Treatment, Sterilizer, Compress Air and Steam Turbine Combined/Cogeneration.
- Validate: Analytical/Process Instruments, Packaging (Equipment/Serialization/3D Designed), Compress Air/Steam, Clean Validation, Computers Software, HVAC/Clean Rooms, Aseptic Filling, Solid Dose, Product/Process and Sterilization (Steam/Ethylene Oxide/Gamma).
- Write and execute test scripts Installation Qualification, Operation Qualification and Performance Qualification (IQ/OQ/PQ).
- Engineer Consultant: Instrumentation/Equipment Installation, Renovating/Construction, Validation and Quality Assurance.
- Perform Factory Acceptance Test (FAT) and Site Acceptance Test (SAT).
- Provide leadership and training in process validation, software validation, test method validation and data analysis.
- Quality Assurance overseeing all FDA/ISO/EU/CMDR compliance.
- Perform instrument calibration per ISO/ANSI/NIST or any government regulation requirements.
- Write all Standard Operation Procedure (SOP) used for Instrument Calibration, Maintenance, Packaging, Production, Process and Quality Assurance FDA/ISO/EU/CMDR.
- Insure that all projects are in compliance with cGMP, GLP, QSR (including Design Controls), ISO or other applicable requirements.
Topics:
validation engineer
Nick Trompert
Nick Trompert is a Sr. Manager. He is responsible for connecting with the best engineering and information technology talent and resources in the world. He is one of the founders of Talent 101 and joined full time after college.
nickt@talent-101.com
