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.
Provide insight and individual contribution in obtaining and maintaining compliance with ICH Q7 guidance for active pharmaceutical ingredients. Troubleshoot method and process issues in assurance of successful validation. Recommend technical design/changes to improve efficiency, quality or performance in support of validation.
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.