Pharmaceutical Specialist

Blackfield Associates are currently supporting an exciting biopharmaceutical manufacturing organisation to recruit for a Validation / Senior Validation Specialist to join the organisation initially on an 18-month FTC basis. The role is to support the qualification and validation of manufacturing systems designed for the production of high-quality drug products, supporting clinical trials and future commercial programs. Perform qualification and validation of manufacturing equipment, analytical test equipment, facilities, services, computerised systems and processes. Author validation lifecycle documents, including risk assessments, GAMP assessments, and various qualification stages (Design, Installation, Operational, Performance). Conduct validation testing with third-party vendors and suppliers. Participate in and support internal and regulatory quality inspections. Biotechnology, pharmaceutical, or medical device industry experience. Strong understanding of cGMP and pharmaceutical quality systems (change control, deviation, CAPA). BS or MS in Engineering or a science-based discipline. Familiarity with regulatory guidance governing cell-based and biopharmaceutical development.