Senior CQV Engineer
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| Job Type | Contractor |
| Location | Dublin |
| Area | Dublin, Ireland |
| Sector | Engineering |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 1002793 |
| Job Views | 94 |
- Description
- Team Horizon is seeking a Senior CQV Engineer (initial 12-month contract) for our client who are a leading biopharmaceutical company based in Dublin. In this role you will be commissioning and Qualification (C&Q) engineer for various capital projects. You will ensure the C&Q activities associated with various capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements.
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.
Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Coordinates and Supervises all C&Q activities.
Generate C&Q planning documents detailing overall strategy for the project.
Develops the master list of C&Q test documents and activities.
Generates all C&Q summary reports.
Ensures the C&Q schedule is developed and maintained.
Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Qsr)
Manages Daily C&Q coordination meetings.
Responsible for Overall Tracking and Reporting of C&Q status and risks/issues.
Ensures Startup of equipment/utilities is completed in a safe and coordinated
manner.
Assist in the development of User Requirement Specifications (URS’s) and Quality
Risk Assessment for Equipment and Automated Systems (QRAES)
Any other duties as assigned.
What you need to apply:
6+ years experience in Engineering or Commissioning and Qualification Management
Technical qualification at third level or equivalent in Engineering.
Extensive knowledge and demonstrated experience managing Commissioning and
Qualification for Pharmaceutical / Biotechnology projects.
Experience of sterile / biotech equipment within the pharmaceutical industry is
preferred.
Knowledge of safety, GMP and environmental regulatory requirements.
Demonstrated strong Communication and Leadership skills.
Demonstrated ability to collaborate with senior stakeholders to achieve optimal
outcomes.
Strong understanding of a risk based approach to commissioning and qualification
within the biotechnology industry
