Validation Engineer

Objectives To own and support validation activities in a Medical Device regulated environment. Responsibilities Own and support validation activities in a Medical Device regulated environment. Responsible for assigned Process / Equipment / Facility / Utility / Software and Computer System Validation as assigned. Generate Validation Plans, Protocols and Reports in support of assigned validation activity. Resolution of Problems encountered during validation. Ensure Consistency in validation/qualification approach across systems and projects. Provide guidance and direction in the preparation and execution of validation activities Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance. Maintain Validation system including conducting Periodic Reviews. Participate in change control processes for manufacturing Process / Equipment / Facility / Utility / Software and Computer System modifications. Quality: Assure ongoing compliance with quality and ind...