OPPORTUNITY OPEN TO FREELANCE OR TEMPORARY EMPLOYED CONSULTANT.

Make your mark for patients
We are looking for a CSV Commissioning and Qualification (C&Q) Engineer who is detail-oriented, proactive, and collaborative to join us as a freelance in Braine-l’Alleud, Belgium.

ABOUT THE ROLE

As a freelance CSV C&Q Engineer, you will act as UCB’s CSV C&Q Subject Matter Expert, providing expertise and leading the CSV C&Q portion of the project. You will ensure that C&Q activities are completed safely, on schedule, and in compliance with system requirements, specifications, and project procedures/guidelines. Your role will be transversal across GMP equipment.

WHAT YOU WILL DO

• You act as CSV C&Q Subject Matter Expert and Compliance lead for CSV.
• You provide guidance to suppliers and the UCB team in all CSV C&Q activities.
• You lead the CSV C&Q strategy based on CSV VMP.
• You liaise with IT SMEs for correct implementation and testing.
• You liaise with automation SMEs for correct implementation and testing.
• You draft or provide technical guidance on document drafting.
• You drive correct CSV verification testing, compliance, and acceptance.
• You conduct troubleshooting, deviation investigation, and resolution.
• You generate and review change controls related to CSV C&Q.
• You ensure relevant training for personnel performing C&Q activities.

INTERESTED? FOR THIS ROLE, WE ARE LOOKING FOR THE FOLLOWING EDUCATION, EXPERIENCE, AND SKILLS

• 3+ years of Lead/SME experience in International CAPEX Commissioning and Qualification.
• Technical qualification at the third level or equivalent in Engineering.
• Extensive knowledge and demonstrated experience delivering CSV Commissioning and Qualification for Pharmaceutical/Biotechnology projects.
• Strong understanding of a risk-based approach to CSV commissioning and qualification.
• Experience with ISPE best practices, GAMP-5, Annex 15 GMP EU, Eudralex Annex 1, ASTM E2500, electronic execution.
• Experience with sterile/biotech/single-use equipment in the bio-pharmaceutical industry is preferred.
• Knowledge of safety, GMP, and environmental regulatory requirements.
• Ability to make decisions under pressure and demonstrated strong communication/leadership skills.
• Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
• Fluent in English; knowledge of French is a plus.
  

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Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!