Cell Therapy Process Validation Lead for Tech Transfer & GMP

Pauwels Consulting; Beerse; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Cleanroom experience

Job summary

Pauwels Consulting is seeking a validation professional to support the start-up of a new biotech production facility. The role focuses on technical transfers, sterilization validation, and equipment introduction to expand therapeutic manufacturing capacity.

You will define validation strategies, coordinate PPQ, hold time studies, APS, and prepare plans, protocols, and reports. You will ensure cGMP compliance, lead improvement projects, and collaborate with cross-functional teams.

Qualifications

• Bachelor’s degree or higher in engineering, biotechnology, biomedical sciences, or pharmacy.
• Pharma/biotech industry experience with product introductions and manufacturing unit operations.
• Strong working knowledge of cGMP and validation methodologies.
• Experience in project management with accurate reporting on activities.
• Proactive team player who can handle pressure and prioritize tasks.
• Fluent in Dutch and English.

Responsibilities

• Define strategies and coordinate validation activities including PPQ, smoke studies, hold time validation, and APS.
• Provide technical guidance on all aspects of validation and qualification for the manufacturing site.
• Manage the revalidation of manufacturing and sterilization processes to ensure continuous compliance.
• Draft, review, and approve validation plans, protocols, and reports for APS and sterilization procedures.
• Contribute to product transfer and system introduction teams to facilitate site development.
• Lead system and process improvement projects focused on operational optimization.
• Monitor technical reports to ensure procedures align with current cGMP and regulatory requirements.

Skills

Pharma/biotech industry experience

cGMP knowledge

Validation methodologies

Project management

Reporting on project activities

Dutch and English fluency

Education

Bachelor’s degree or higher in engineering/biotech/pharmacy

Job description

Pauwels Consulting is seeking a validation professional to support the start-up of a new biotech production facility. The role focuses on technical transfers, sterilization validation, and equipment introduction to expand therapeutic manufacturing capacity.

You will define validation strategies, coordinate PPQ, hold time studies, APS, and prepare plans, protocols, and reports. You will ensure cGMP compliance, lead improvement projects, and collaborate with cross-functional teams.