Commissioning & Qualification Engineer

Job type:
on-site
Start:
09/2018
Duration:
12 months
Place:
Brussels
Date:
08/22/2018
Country:
flag_no Belgium
project ID:
1619000

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Senior Commissioning & Qualification Engineer
Brussels, 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.