Senior MSAT Sterile Process Lead Tech Transfer & Validation

UCB - Union Chimique Belge; Eigenbrakel; On-site; EUR 100,000 - 140,000; Full time

Job summary

UCB - Union Chimique Belge in Belgium seeks an experienced MSAT DP Sterile Process Lead to drive aseptic processing and technology transfer for sterile drug product manufacturing, including isolator-based filling and contamination control.

You will lead cross-functional projects, provide technical leadership, and ensure compliance with cGMP and regulatory expectations across the product lifecycle.

Qualifications

• Master's degree or higher in a relevant engineering or pharmaceutical discipline.
• 8+ years of experience in sterile pharmaceutical manufacturing or MSAT.
• Proven expertise in aseptic processing and isolator technologies.
• Knowledge of Annex 1, FDA guidance, cGMP and contamination control.
• Experience with facility start-up, qualification, validation and manufacturing.

Responsibilities

• Design, start-up, qualification and readiness of new sterile facilities and operations.
• Lead technology transfer and industrialization projects across functions.
• As SME, provide oversight for sterile processes ensuring regulatory compliance.
• Drive investigations, root-cause analysis and CAPA implementation.
• Author and review technical protocols, validation reports and regulatory docs.
• Serve as technical authority during audits and inspections.
• Lead a Sterile Manufacturing Community of Practice and knowledge sharing.
• Participate in due diligence for site selection and strategic investments.
• Manage project scope, timelines, resources, budgets and risks.

Skills

Aseptic processing

Technology transfer

Regulatory knowledge

Root-cause analysis

Education

Master's degree in Engineering

Master's degree in Pharmaceutical Sciences

Master's degree in Chemical Engineering

Job description

UCB - Union Chimique Belge in Belgium seeks an experienced MSAT DP Sterile Process Lead to drive aseptic processing and technology transfer for sterile drug product manufacturing, including isolator-based filling and contamination control.

You will lead cross-functional projects, provide technical leadership, and ensure compliance with cGMP and regulatory expectations across the product lifecycle.