Contractor Assignment: Senior CSV Commissioning and Qualification (C&Q) Engineer

JOB DESCRIPTION

Opportunity open to freelance or temporary employed consultant.

Make your mark for patients

We are looking for a Senior CSV Commissioning and Qualification (C&Q) Engineer who is experienced, detail-oriented, and a strong leader to join us as a contractor in our Genesis team, based in our campus site of Braine l’Alleud.

About the role

As a Senior CSV Commissioning and Qualification (C&Q) Engineer contractor for UCB, you will act as UCB CSV C&Q Subject Matter Expert, providing expertise and leading the CSV C&Q portion of the project to ensure the C&Q activities are completed safely, as per schedule, and in compliance with the system requirements, specifications, and project procedures/guidelines. This is a transversal role across GMP equipment.

Who you’ll work with

You will be working in an integrated team, collaborating closely with suppliers, IT SMEs, compliance teams, and the rest of the UCB team to ensure successful CSV C&Q activities from design to field execution and summary report approval.

What you’ll do

• You act as CSV C&Q Subject Matter Expert and Compliance lead for CSV, providing guidance to suppliers and the UCB team.
• You lead Lead the CSV C&Q strategy based on CSV VMP, including: 21-CFR-Part 11 aspects: Audit trail, Electronic records, Electronic signatures, System security/Access management, Data import/export, Backup/DRP and Automation aspects for PCS (DCS)/EMS/BMS and integrated systems: Graphics/IO, Interlocks, e-stop, communication or power loss, Trending, Alarms, errors, Regulation and control loop, Automation design documentation, configuration verification, HDS testing, FDS Sequence testing, Parameters, Recipe creation and management, Batch/cycle/analysis report.
• You draft or provide technical guidance on document drafting, coordinate review and approval of applicable CSV C&Q documents.
• You drive correct CSV verification testing, compliance, and acceptance. You conduct troubleshooting, deviation investigation, and resolution for issues encountered during execution activities.
• You generate and review change controls related to CSV C&Q and drive closure in a timely manner.
• You ensure all personnel performing C&Q activities for the system(s) have relevant training assigned.

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

• You have 5+ years of Lead/SME experience in International CAPEX Commissioning and Qualification.
• You possess technical qualification at third level or equivalent in Engineering.
• You have extensive knowledge and demonstrate experience delivering CSV Commissioning and Qualification for Pharmaceutical/Biotechnology projects.
• You demonstrate a strong understanding of a risk-based approach to CSV commissioning and qualification within the biotechnology industry. Experience with ISPE best practice/GAMP-5/Annex 15 GMP EU/Eudralex Annex 1, ASTM E2500/electronic execution.
• You have experience with sterile/biotech/single-use equipment in the bio-pharmaceutical industry is preferred.
• You can make decisions under pressure and demonstrated strong communication/leadership skills.

#genetherapy

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! 

About UCB

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science. 

Why work with UCB? 

At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. 

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

Employment or engagement

If you have been selected to work for UCB, please note that you will be formally employed by a staffing agency (in case of being a temporary employed consultant) or engaged via a broker (in case of being a freelancer), to work for UCB.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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