CQV Systems Owner (Lead)
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Engineering |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Telephone | 01 574 6266 |
| Job Ref | 2805 |
| Job Views | 2 |
- Description
- Team Horizon is seeking a HVAC CQV System Owner (Lead) to be part of our client’s team who are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. This is a 12-month contract initially.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
This role offers the opportunity to take on a Lead position with the CQV team on site.
What you will be doing:
The CQV System Owner performs activities to support the Risk Based Verification (RBV) commissioning and qualification activities in a cGMP manufacturing plant and subsequent validation activities. The role is a contract position as part of the CQV team.
Commissioning and qualification of Sterility Test Isolator system in accordance with ISO13408-6 Part 6 Isolator Systems and PICS PI014-3 Isolators Used for Aseptic Processing and Sterility Testing.
HVAC and Cleanroom Systems Validation and Qualification within a live production facility.
Packaging Line and Packing Systems Validation and Qualification and support.
What you need to apply:
10 years HVAC commissioning and Validation experience within the BioPharmaceutical Industry
Degree in Engineering/Life Sciences
Excellent technical abilities with a solid base in engineering.
Strong technical writing and communication skills.
Proven track record in generation of validation/verification documentation.
