MSAT DP Sterile Process Lead

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

MSAT DP Sterile Process Lead

UCB - Union Chimique Belge

Braine L'alleud or Bulle

About the role

This role combines deep expertise in aseptic processing, technology transfer, facility start-up, contamination control and operational excellence.

As a recognized Subject Matter Expert (SME), you will play a key role in supporting the design, qualification and operation of next-generation sterile manufacturing facilities, including isolator-based filling technologies. You will serve as a key technical partner to Manufacturing, Quality, Engineering, Validation and Regulatory teams while driving continuous improvement and fostering technical excellence across the organization.

You will lead the operational delivery of sterile drug product technology transfers from process scale-up through commercial validation and the full product lifecycle.

This position is ideal for an experienced professional passionate about sterile manufacturing, problem solving, knowledge sharing and technical leadership.

What you’ll do

• Participate in the design, start-up, qualification and operational readiness of new sterile manufacturing facilities, including isolator-based filling operations, contamination control strategies, aseptic process simulations and process validation activities.
• Lead cross-functional technology transfer and industrialization projects for sterile drug product manufacturing, ensuring alignment across Manufacturing, Quality, Regulatory Affairs, Validation, Engineering, Analytical Sciences and Supply Chain.
• As a subject matter expert (SME) for aseptic processing and sterile manufacturing technologies, provide technical oversight for sterile manufacturing processes, ensuring compliance with global regulatory expectations, cGMP requirements and industry best practices.
• Drive second-line technical troubleshooting for complex manufacturing issues, leading structured investigations, root-cause analyses, risk assessments and implementation of sustainable CAPAs.
• Author, review and approve technical protocols, validation documentation, internal standard, study plans, reports, investigations, trend analyses and scientific justifications supporting manufacturing operations and regulatory submissions.
• Serve as a technical authority during audits, inspections, regulatory interactions and due diligence activities related to sterile manufacturing operations.
• Lead a Sterile Manufacturing Community of Practice by sharing best practices, industry trends, lessons learned and emerging technologies, while developing organizational knowledge and technical capabilities to the organization.
• Contribute to due diligence for manufacturing site selection, technology assessments and strategic investments by evaluating technical capabilities, operational readiness and compliance risks.
• Manage project scope, timelines, resources, budgets, risks and mitigation plans to ensure successful execution of MSAT objectives and business priorities.

For this role we’re looking for the following education, experience and skills:

• Master's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemical Engineering or related discipline.
• 8+ years of experience in sterile pharmaceutical manufacturing, MSAT, Process Engineering, Technical Services or Manufacturing Support.
• Demonstrated expertise in aseptic processing, contamination control and isolator technology.
• Strong understanding of Annex 1, FDA aseptic processing guidance, cGMP requirements and contamination control principles.
• Experience supporting facility start-up, qualification, process validation and commercial manufacturing.
• Proven experience leading complex investigations and troubleshooting multidisciplinary manufacturing issues.
• Experience authoring and reviewing technical protocols, validation reports and regulatory-supporting documentation.
• Strong presentation, communication and influencing skills with the ability to act as a recognized SME across multiple functions.
• Experience facilitating technical forums, communities of practice or knowledge-sharing networks is highly desirable.
• Fluent written and spoken English, with the ability to summarise complex topics and present clear options.