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 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.
Give attention to detail, perform critical analysis of situations and provide recommendations, work independently with structured guidance, good follow up skills, clearly define and communicate issues both verbally and in writing.