MSAT DP Sterile Process Lead

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.
Interested?
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.
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UCB - Union Chimique Belge