Senior CSV Engineer

A leading company in the biotechnology industry is seeking a Senior CSV Engineer to join their team in the Walloon Region, Belgium. This role requires expertise in a dynamic environment, ensuring that C&Q activities are executed safely, on schedule, and in compliance with system requirements and project guidelines.

As the Senior CSV Engineer, you will be responsible for supporting Commissioning and Qualification activities for Process Equipment / PCS7 from a computerised systems point of view.

This mission is mainly execution focused, so you are expected to be on site most of the time. This mission is to start as soon as convenient, for an initial 6 months.

Your duties as the Senior CSV Engineer will be varied however the key duties and responsibilities are as follows:

1. As the Senior CSV Engineer, you will acting as the CSV C&Q Subject Matter Expert and Compliance lead, providing guidance to suppliers and the team in all CSV C&Q activities from design to execution and report approval.

2. Leading the CSV C&Q strategy based on the CSV Validation Master Plan, including aspects such as 21-CFR-Part 11 compliance, automation for PCS/EMS/BMS, and integrated systems.

3. As the Senior CSV Engineer, you will Drafting or providing technical guidance on document drafting, coordinating reviews, and approvals of applicable CSV C&Q documents.

4. Driving correct CSV verification testing, compliance, and acceptance, troubleshooting issues during execution activities, and ensuring timely closure of change controls related to CSV C&Q.

To be successful in your application to this exciting role as the Senior CSV Engineer we are looking to identify the following on your profile and past history:

1. Technical qualification at third level or equivalent in Process Engineering, Automation Engineering or related discipline to work as a CSV Engineer.

2. Extensive knowledge and demonstrated experience delivering CSV Commissioning and Qualification (C&Q) for Pharmaceutical/Biotechnology projects. Biologics / Cell and Gene Therapy experience would be an advantage.

3. A working knowledge and practical experience with a risk-based approach to CSV commissioning and qualification (C&Q) within the biotechnology industry.


Key Words: / Senior CSV Engineer / Commissioning and Qualification / Biotechnology / Pharmaceutical / GMP / 21-CFR-Part 11 / Automation / Compliance / Risk-Based Approach / Validation Master Plan / CSV Engineer / ISPE / Biologics / Cell Therapy / Cell and Gene Therapy / CGT