Description
Qualification Engineer (Utilities Package)
Start: Immediate
Duration: 6 - 12 months
Language: French
Our client is a biopharmaceutical company, one of the rare manufacturers in the world with expertise in different bio-production techniques.The site in France has undergone an expansion project & therefore requires external support in the Qualification of the Utilities package on site. The Qualification Engineers will work on the client side to ensure qualification activities are being completed in a timely and effective manner.
Tasks and Duties:
- Preparation of qualification documents for templates (qualification plan, URS review, risk analysis, qualification report, Test Protocols, Reviews, etc.)
- Implementation of IQ/OQ/PQ/DQ (plans/test protocols/reports, reviews).
- Process Qualification.
- Automation Qualification (Knowledge of WonderWare beneficial).
- Carry out qualification testing (smoke testing method).
- Supervise Qualification team of the subcontractor.
- Manage change control process.
- Deviation Management.
- Review of Change Controls.
- Experience with: Equipment - (Tanks/skids/pumps/precipitation tanks).
- Experience with: Clean & Black Utilities/Purified WfI systems/HVAC systems.
- Exposure to biotech is essential (Min. 5 Years).
- Excellent GMP knowledge.