C&Q Engineer
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| Job Type | Contractor |
| Area | Westmeath |
| Sector | Engineering |
| Start Date | |
| Advertiser | Hilda Lynn |
| Telephone | +353 98 33013 |
| Job Ref | #1002468 |
| Job Views | 293 |
- Description
- C&Q Engineer – Team Horizon
We are seeking applications for an experienced C&Q Engineers to support New Product Introduction in our client’s Biologics Facility in the Midlands. As the C&Q Engineer will be responsible for Installation and Operational tests execution, protocol generation and results reporting on process equipment and utilities systems.
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.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
What you will be doing:
Understanding of the ASTM E2500 Qualification Requirements
Understanding of the system/equipment qualification lifecycle: URS to Operational phase
Direct Experience with hands on execution of System/equipment Mechanical Completion, Installation Verification and Functional Verification Testing
Understanding of the Quality Risk Management within qualification requirements
Understanding of manufacturing equipment used in Biologics and Drug Product Processes
Understanding of the Utilities Systems and systems and their CQAs (Clean Steam, WFI, HVAC, process gasses)
Understanding of the Aseptic and Biologics Manufacturing processes and contamination control
Understanding of the BMS systems and Automation architecture
Understanding of the ASME BPE – Bioprocessing Equipment Requirements
Understanding of the Quality System Elements:
Deviation
CAPA
Calibration
Preventative maintenance
Change Control
What you need to apply:
Bachelor’s Degree or Relevant Experience
Typically, 3+ years Validation engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment
Experience in MS Office, MS Project, Change Control & Document Management Systems
Ability to work to tight deadlines in a fast-moving environment