Validation Engineer II (377)

Lead the development and execution of commissioning, qualification, and validation protocols for equipment, systems, and critical utilities (CCA, N2, Clean Steam) for a biologics facility expansion. Serve as the CQV subject matter expert and guide CQV activities through all lifecycle phases, including defining requirements, planning, protocol generation, final summary reports, test execution, and documentation release. Author, review, and execute CQV documentation and related procedures; manage Change Controls and change actions; develop SOPs for new processes and equipment; collaborate across operations, engineering, QA, IT, and vendors; oversee exploration of continuous improvement for validation processes; require strong leadership and cross-functional influence. Preferred background includes sterile fill-finish, single-use components in drug product formulation, and startup experience; advanced degrees or certifications related to CQV are a plus; capable of working in a fast-paced, multi-disciplinary team and delivering on time in a start-up-like facility expansion.