C&Q Engineer
| Job Type | Contractor |
| Area | Westmeath |
| Sector | Engineering |
| Start Date | |
| Advertiser | Hilda Lynn |
| Telephone | +353 98 33013 |
| Job Ref | #1002468 |
| Job Views | 140 |
- 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
