Validation Engineer

Summary:
Writing and execution of validation protocols and reports ( IQ, OQ, PQ, etc.)

Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness, investigations, root cause analysis, problem solving and report or presentation preparation.

Updating procedures, manufacturing specifications, bills, routes and travelers for product & process changes in the PLM system.

Roles & Responsibilities:

Working with OEM equipment manufacturers and distributors to develop user requirements.

Work on new asset commissioning.

Working with multi-functional teams (Operations Value Stream, OpEx, Planning, Engineering, and Quality) to align on validation strategy, author validation documents, coordinate execution and document approvals.

Ensuring compliance with Food and Drug Administration (FDA) regulations, other regulatory require...