Manager CSV-Execution Automation Systems

Role: Automation Engineering Manager, Execution Systems CSV Lead, overseeing CSV strategy and lifecycle management for automation and IT systems in biopharmaceutical manufacturing. Responsibilities: develop and execute CSV protocols, ensure compliance with cGMP and industry standards (e.g., ISA S95, S88, GAMP 5), support validation, data integrity, and continuous improvement initiatives; manage projects, resources, and team; collaborate with Quality, IT, and Operations; act as site CSV point of contact; track metrics and KPIs. Requirements: BS in Engineering, Science, or related field; at least 8 years' experience in pharmaceutical/biopharma manufacturing, with a minimum of 2 years in automation, execution systems, or IT roles; expertise in automation platforms (Emerson DeltaV, Siemens PLCs), MES systems (Werum PAS-X), and related industry standards; knowledge of cGMP regulations and validation processes. Preferred: management experience, process knowledge across upstream/downstream bioprocessing, familiarity with GAMP 5. High-Value: biopharma manufacturing, GMP compliance, automation, and IT in a regulated environment; focus on clinical or commercial bioprocessing. Location: Wilson, North Carolina; full-time onsite with >50% travel until project completion.