Freelance CQV Engineer
Job Title: Freelance CQV Engineer
Location: On-site, 5 days/week (Ireland)
Industry: Pharmaceutical
Contract Type: Freelance/Contract
Duration: 12 month
Start Date: August/September
About the Role:
We are seeking an experienced CQV Engineer to support a pharmaceutical client on-site in Ireland. This is a hands-on role requiring full-time presence on-site, working closely with cross-functional teams to ensure successful delivery of CQV activities across multiple systems and equipment.
Key Responsibilities:
Develop and execute CQV protocols (IQ/OQ/PQ) for pharmaceutical manufacturing equipment and utilities.
Support commissioning and qualification of cleanrooms, HVAC, autoclaves, process equipment, and critical utilities (WFI, PW, Clean Steam).
Collaborate with engineering, QA, and operations teams to ensure compliance with GMP and regulatory standards.
Review and approve vendor documentation, FAT/SAT protocols, and validation reports.
Troubleshoot and resolve issues during commissioning and qualification phases.
Maintain accurate and complete documentation in line with project timelines and quality standards.
Requirements:
Proven experience in a CQV role within the pharmaceutical or biotech industry.
Strong knowledge of GMP, FDA, and EU regulatory requirements.
Experience with equipment and utility qualification in sterile or aseptic environments.
Excellent documentation and communication skills.
Ability to work independently and as part of a multidisciplinary team.
Right to work in Ireland (visa/work permit if applicable).
Desirable:
Experience with CSV (Computer System Validation) is a plus.
Background in engineering, life sciences, or a related field.
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