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A specialized Medical Device CDMO in Northern LA, CA is in immediate need of a Validation Engineer for a 6-month project. The project needs to be completed while working every day onsite.

The client company is growing rapidly and there is now a growing list of pieces of lab equipment that need to be qualified in support of a backlog. The Validation Engineer needs to be an expert with lab equipment like Agilent HPLCs, GCs, centrifuges, and Analytical Balances among other types of instruments.

Top Requirements:

• 5+ years of direct lab experience validating lab equipment, this experience must be clearly detailed in CV
• 5+ years of experience as a Validation Engineer working with Medical Device and Pharmaceutical companies
• BS degree minimum
• Strong knowledge of FDA standards and regulations, especially regulations for labs
• Strong experience working in a lab setting to qualify a range of equipment/instruments like:
• HPLC
• GC / GC Headspace Sampler
• Microbalances / Analytical balances
• Centrifuges
• Strong expertise reading User Requirements from vendors and translating them to protocols for qualification
• Experience communicating with equipment vendors
• Must be an expert in developing and executing validation protocols (IQ/OQ/PQs)
• Strong communication skills and a team player

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