Description
Senior Commissioning & Qualification EngineerBrussels, Belgium
12 months
€70/hr
Optimus Life Sciences are working with a Global Biotechnology Company based in Brussels, Belgium and together we are looking for multiple System Owners for a site start-up project.
This project will last a minimum of 12 months initially. The proposed started date is 3rd September but can be flexible, interviews will take place as early as next week.
Overview
As the C&Q System Owner, you will perform activities supporting the Risk Based Verification C&Q tasks in the cGMP BDS manufacturing plant. You will also lead the CQV team focusing on;
- Commissioning Bio-Process systems with DeltaV automation.
- Co-ordination of Combined CQV Team.
- To review & approve automation FDS for DeltaV (CM's, EM's, Graphics & Phases).
- To have a detailed knowledge of specific Bio-Process and Clean Utility unit operations.
- Draft, review and approve CQV test documentation.
- Input into the core aspects of Operations, Qualification and Validation SOP's.
- Have a minimum 5 years CQV experience in Bulk Drug Substance Manufacturing Facility.
Requirements
- Working on early Pharma/ Biotech facility start-up projects.
- Reviewing P90 Drawings.
- Approving tenders for Biotech equipment.
- Have managed a design consultancy ensuring they meet set targets and milestones.
- Problem solving and Project Management skills.
- Must be goal-oriented and able to prioritize and manage risks.
If this role sound interesting, please contact me for more details.