CQV Engineer - Isolators
- Old Nangor Rd, Kilmahuddrick, Dublin 22, Ireland, County Dublin (IRL)
- Negotiable
- 26 Weeks
- Start date: 07 Jun 22
- Ref: 5082225
- cqv
- isolator
Job description
Posted 08 June 2022
A market-leading Biopharmaceutical/Cell Therapy company in Dublin is now looking for a CQV Engineer an initial 12-month contract!
The Job:
- Support the commissioning and qualification of all process equipment, facilities, and utilities.
- Isolator experience is must.
- Writing, reviewing, and approving IQ, OQ, PQ protocols.
- Plan and coordinate the Commissioning and Qualification (C&Q) activities throughout all project phases in close coordination with internal and external interfaces
- Review third party documents to support C&Q requirements.
- Develop (or support/ review) user requirement specifications, and quality impact assessments as well as GMP risk assessments
- Complete the development, review, and execution of plans, as well as protocols/reports.
- Ensure C&Q non-conformances or deviations are minimized during execution of C&Q activities.
- Supervise vendors/ contractors on site during their C&Q activities, including FAT and SAT.
- Review vendor technical documentation with regard of C&Q requirements
- Ensure compliance with current industry guidelines relating to C&Q.
- Participate in the control of Safety and Environmental programs.
- Adhere to safe working practices as set out in the Safety Statement and other company safety rules.
Have you:
- 5+ years’ experience in demanding GMP environments.
- Bachelor’s degree in a relevant Scientific / Engineering discipline.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Eoghan Fitzgerald at +353 (0) 85 250 8120 or send your profile to efitzgerald@berkley-group.com
