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Cqv engineer

Dublin
Russell Tobin
Cqv engineer
Posted: 18 October
Offer description

Small Equipment Commissioning & Qualification (C&Q) EngineerLocation: Dublin| On-siteContract | Full-timeWe are looking for an experiencedSmall Equipment Commissioning & Qualification (C&Q) Engineerto join our team at aSterile Drug Product manufacturing facility. The successful candidate will support the commissioning, qualification, and validation of equipment and utilities in compliance withGMP,EU, andFDAregulations.Key ResponsibilitiesDevelop, review, and execute CQV protocols and testing documentation for small process and lab equipment including benchtop, mobile, analytical, PAT, incubators, biosafety cabinets (BSCs), and temperature control units (TCUs).Ensure commissioning and qualification activities comply with site and global procedures.Manage deviations, risk assessments, and change controls related to equipment and utilities.Perform and document FAT (Factory Acceptance Testing) and integrate results into qualification packages.Support project deliverables including safety, CQV schedule, and quality documentation .Maintain compliance with Good Manufacturing Practice (GMP) requirements and ensure audit readiness.Collaborate with cross-functional teams including engineering, validation, and manufacturing to achieve project milestones.Complete all assigned training in line with site metrics and compliance standards.Required Skills & ExperienceProven experience in CQV execution from design through qualification and handover.Hands-on experience in commissioning and qualification of small equipment and automation-integrated systems within Drug Product or Drug Substance facilities.Strong understanding of CQV lifecycle, validation documentation, and regulatory compliance .Experience with electronic validation systems such as ValGenesis or Kneat .Excellent organizational, communication, and teamwork skills with the ability to work effectively in a matrix environment .Strong problem-solving and analytical skills with attention to detail.QualificationsBachelor's degree (BSc/BEng) in Engineering, Science, or a related technical discipline .Minimum 3–5 years of pharmaceutical or biotech industry experience, preferably with exposure to Sterile Drug Product filling operations .Comprehensive understanding of EU GMP, FDA, and GAMP 5 guidelines.Why JoinBe part of a high-performing CQV team driving excellence in sterile manufacturing.Opportunity to work in a cutting-edge facility with advanced automation and validation systems.Collaborate with experienced professionals on global-scale pharmaceutical projects

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