Manufacturing Manager Programs – Cleaning Validation
Core
Lead the development and implementation of the Validation strategy for a biologics manufacturing facility, focusing on cleaning validation, sterilization, and equipment qualification.
Role type
Senior Manufacturing Manager (Validation)
Builds
Drug substance manufacturing operations at a new advanced facility
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
Cleaning validation, Sterilization validation, Equipment qualification, Validation strategy development, Regulatory compliance (FDA/EMA), Team leadership, Technical writing
Preferred skills
Biologics facility expertise, Change administration, Regulatory submissions support, Continuous improvement initiatives
Technologies
Autoclaves, Controlled temperature chambers (CTC), Stainless-steel equipment, Disposable technologies
Responsibilities
Lead team for cleaning validation and sterilization program, Provide technical support for commissioning and qualification, Collaborate on project results for equipment validation, Generate and review cleaning validation documents, Coordinate with cross-functional teams, Support regulatory filings and audits, Maintain validation master plan
Seniority
Senior, hands-on IC with management responsibilities