CQV Engineer
Employer undisclosedRole managed by a recruiter
Develop and execute CQV testing documentation for filling line systems in a sterile drug facility.
21 days ago ago
Expert & Leadership (13+ years), Intermediate (4-7 years), Experienced (8-12 years)
Contractor
Dublin, County Dublin, Ireland
Onsite
Role
What you would be doing
gmp testing
cqv testing
commissioning
safety compliance
documentation
regulatory compliance
- Responsible for ensuring GMP equipment are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
- Development and execution of CQV testing documentation for filling line systems including Syringe and Vial line/ isolators, Lyos and associated equipment for the Sterile Drug product facility. 100%
- Responsible for ensuring that all equipment, is tested in compliance with project related standards from a commissioning perspective.
- Responsible for meeting key project deliverables for safety, CQV schedule and quality of project related documentation/electronic records for equipment, utilities assigned.
What you bring
cqv
automation
sterile manufacturing
project lifecycle
team collaboration
budget management
- CQV project lifecycle experience from design through to C&Q and handover.
- Experience in CQV of Drug Substance/Drug product sterile manufacturing equipment with integrated automation.
- Demonstrable experience of performing as part of diverse team of CQV professionals/ contractors to deliver on tasks safely, with quality focus, on time and within budget.
- Demonstratable capacity to effectively execute the CQV testing approach for assigned from initiation to completion.
Information not given or found
Training + DevelopmentInformation not given or found
Interview process
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Visa SponsorshipInformation not given or found
Security clearanceInformation not given or found
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