The Validation Engineer II is responsible for all aspects of the validation process, including: documenting commissioning activities, coordinating F.A.T. and S.A.T. testing, establishing the process and equipment acceptance criteria, and developing and performing qualification studies to document evidence which provides a high degree of assurance that equipment and processes (including cleaning processes) will consistently produce a product meeting its predetermined specifications and quality attributes.
Must have demonstrated experience and a high level of understanding while validating a wide range or equipment and processes (including cleaning processes), including mixing, sterile fill, freeze drying, parts washers, vial washers, wet steam and dry heat sterilization and packaging.
The incumbent will interface directly with personnel from all levels of the Engineering, Manufacturing, Quality, Regulatory Affairs, Program Management, Research and Development, Commercial, and Supply Chain organization.