Senior Specialist, Associate Aseptic Process Validation Engineer

Role: Senior Specialist, Associate Aseptic Process Validation Engineer supporting Bristol Myers Squibb’s cell therapy facility. Objectives include executing aseptic process simulations, validations, and performance qualifications to ensure cGMP compliance and manufacturing readiness. Responsibilities involve authoring qualification/validation documents, leading risk assessments, managing change controls, supporting investigations, and maintaining inspection readiness. The role requires cross-functional collaboration and active regulatory inspection support. Qualifications include a bachelor’s degree in science, engineering, or related field, with at least 2 years’ experience in biopharmaceutical operations, aseptic processing, validation, or clean room design. Knowledge of cGMPs, multi-national biopharma regulations, and experience with audits are essential. High-value specifics: cell therapy modalities, aseptic validation, cGMP compliance, and support for regulatory inspections. The position is onsite at the Devens, MA facility, with standard weekday hours. The role emphasizes teamwork in a highly regulated, innovative environment focused on cell therapy advancements.