CQV Engineer

6 days ago

Cork, Ireland Tandem Project Management Limited Full time

Summary: We are seeking a Packaging Validation Engineer to join our client, a biopharmaceutical company based in East Cork. This role will play a critical part in ensuring packaging systems, equipment, and processes meet regulatory, quality, and safety standards. The successful candidate will support packaging validation projects, new equipment introductions, and continuous improvement initiatives across the site. Responsibilities: Develop, execute, and maintain packaging validation protocols (IQ, OQ, PQ) in compliance with GMP, FDA, and EMA regulations. Lead validation activities for packaging lines, serialization systems, labelling equipment, and related automation. Support new product introductions by validating packaging configurations, artwork changes, and associated processes. Generate and review validation documentation, including risk assessments, validation plans, summary reports, and SOPs. Collaborate with cross-functional teams (Quality, Manufacturing, Engineering, Supply Chain) to ensure timely project delivery. Manage deviations, CAPAs, and change controls related to packaging systems. Monitor equipment and process performance, driving improvements in reliability and compliance. Stay current with regulatory expectations, industry standards, and emerging technologies in packaging validation. Qualifications & Experience: Bachelors degree in Engineering, Science, or related technical discipline. 3+ years experience in validation or engineering within a GMP-regulated environment (biopharmaceutical, pharmaceutical, or medical device). Strong knowledge of packaging operations (filling, labelling, serialization, tamper-evidence, etc.). Familiarity with regulatory guidelines (FDA, EMA, Annex 15, ICH Q9/Q10). Excellent documentation, analytical, and problem-solving skills. Proven ability to work independently and as part of a cross-functional team. Strong project management and communication skills.

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