Process Transfer and Validation Expert

About the Team

The IMS&T team is responsible for leading technology transfers of drug substance manufacturing processes and supporting the introduction of new products into commercial production. We work cross-functionally to ensure smooth, compliant, and timely execution of all transfer, validation and launch activities.

Your Responsibilities

• Lead and support end-to-end Technology Transfer activities as a receiving or sending manufacturing site.
• Coordinate all cross-functional workstreams involved in Technology Transfer, including Manufacturing, Quality Control, Quality Assurance, Engineering and Supply Chain.
• Act as the Single Point of Contact for assigned Technology Transfer projects.
• Develop technical strategies, risk assessments and contingency plans across the full project lifecycle.
• Prepare, review and oversee key Technology Transfer and process validation documentation (plans, protocols, reports, Master Batch Record inputs).
• Monitor process validation campaigns, assess the impact of deviations, provide validation status updates and support dossier preparation for regulatory authorities.
• Coordinate end-to-end readiness for manufacturing campaigns – documentation release, equipment and materials readiness, training and pre-campaign alignment.
• Lead interdisciplinary project teams (10–30 members), manage timelines and ensure compliance with Good Manufacturing Practice (GMP) and Environment, Health & Safety (EHS) standards.
• Assess site resource needs (FTEs, investments, external costs) and support budgeting for Technology Transfer projects.
• Represent the company during meetings with external clients and inspections by Health Authorities (HA).
• Contribute to continuous improvement of Technology Transfer processes, templates and procedures.
• Report project progress, key risks and decisions to the Senior Manager.

Our Expectations

• Higher education in biotechnology, pharmacy, or related fields.
• Minimum 5 years of experience in biotechnology or pharmaceutical manufacturing and/or technology transfer.
• Strong knowledge of GMP, EMA/FDA guidelines and technology transfer best practices.
• Experience in process validation and working with recombinant proteins at production scale.
• Excellent English skills, both written and spoken.
• Ability to work independently, solve problems, and collaborate effectively across teams.
• Proficiency in MS Office and MS Project.