Senior Validation Engineer
3 weeks ago
Summary: Our client is a global biopharmaceutical company based in West Dublin, looking for a Senior Validation Engineer to complete and lead packaging validation activities end-to-end within a GMP environment, preparing the necessary documentation and ensuring audit-ready records throughout the lifecycle. Typical project scope will include qualification and validation of vial labellers, cartoners, carton labelling systems, serialisation and aggregation systems (line controllers, vision systems, printers/coders, L2L4 integrations), and associated inspection and handling equipment. Responsibilities: Management of all equipment & process validation testing documentation, development and execution of protocols and delivery of compliant reports aligned to ALCOA+ and data integrity expectations. Engage at the early stages of validation projects to provide input into design, requirements, and risk assessments; coordinate vendor management and design reviews to ensure validation requirements are embedded and met in line with regulatory expectations (e.g., ISO 11607, 21 CFR Parts 210/211, 21 CFR Part 11, EU MDR, GAMP 5). Plan and execute qualifications, oversee FAT/SAT and commissioning, manage deviations/CAPAs and change control, and partner with cross functional teams (Engineering, Operations, QA, IT) to troubleshoot issues and deliver right first-time outcomes on schedule. Define validation approach in line with site procedures, risk assessments (FMEA), and author VMPs, URS, and lifecycle documents. Create and execute protocols (IQ/OQ , IV/FV, FV and PQ protocols) for packaging lines, inspection systems, and serialisation/aggregation solutions. Own all validation testing documentation, and reports ensuring ALCOA+ compliance and audit readiness. Qualify vial labellers, cartoners, carton labelling, vision systems, printers/coders, and related handling/inspection equipment. Validate serialisation and aggregation systems on the packaging lines and connected IT systems, ensuring correct setup, reliable data, and compliance with relevant market rules. Provide input to design requirements, specifications, and risk mitigation at concept and design review stages. Lead FAT/SAT activities to ensure deliverables meet quality and schedule. Qualify new formats per market requirements, covering artwork/label content, pack configuration, tamper evidence, variable data, and serialization rules; verify printing/vision checks and complete required documentation. Investigate issues, perform root cause analysis, and drive timely CAPA closure and change control updates. Partner with Engineering/Operations/QA/IT to enable right-first-time commissioning and line release. Qualifications & Experience: Technical Degree in Engineering preferred. 5-10 years of experience in a relevant Validation role. Knowledge of Packaging Equipment and Serialisation systems. Strong awareness and understanding of GMP environment. Experience and competency in risk-based validation methods. Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification. Structured RCA Skills: Proficiency with 5-Whys, fault-tree analysis, other RCA methods. Ability to keep work pace and meet deadlines. Good organisation and planning skills.
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Senior Validation Engineer
2 weeks ago
Dublin, Ireland Reperio Human Capital Ltd Full timeSenior Validation Engineer Location: Dublin or Limerick (Hybrid) Sector: Technology / Life Sciences Salary: €70,000 - €85,000 per annum (DOE) We are partnering with a global technology company that develops software solutions for the healthcare and life sciences industry. They are now seeking a Senior Validation Engineer to join their quality and...
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Senior Validation Engineer
4 days ago
Dublin, Ireland Scientificjobs Full timeJob Title: Senior Validation Engineer Location: Pottery Road, Dun Laoghaire, Dublin. Benefits: Competitive salary, Share options, Pension, Healthcare , Annual bonus + excellent opportunity to develop your experience and career in an exciting company. Company: For nearly 100 years, my client have been accelerating the journey to better diabetes care. With the...
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Validation Engineer
16 hours ago
Dublin Pike, Ireland QCS Staffing Full timeValidation Engineer – Ireland, Dublin – 12 Months Initial Contract Our client, a globally recognized pioneer in Biotechnology, is recruiting for the position of Validation Engineer. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to strive for solutions. This is your chance to join them on a...
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Validation Engineer
2 weeks ago
Dublin, Ireland CAI Full timeValidation Engineer – Senior CAI Overview Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 700 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide commissioning, qualification, validation,...
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Dublin, Ireland AstraZeneca GmbH Full timeJob Summary: The Senior Temperature Mapping Validation Engineer will be accountable for planning, executing, analyzing, and documenting temperature mapping activities across critical and Controlled Temperature Units (CTUs) at the Alexion Manufacturing Dublin facility (ADMF). This includes the qualification of fridges, freezers, incubators, cold rooms,...
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Validation Engineer
16 hours ago
Dublin, Ireland Unipharmedtech Full timeValidation Engineer page is loaded## Validation Engineerlocations: CityWest Officetime type: Full timeposted on: Posted Todayjob requisition id: JR-0000006427**Validation Engineer****1 Year Fixed Term Contract****Citywest Head Office****Who Are We Looking For:**As a Validation Engineer, you will be responsible for the validation and coordination of...
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(Immediate Start) Senior Validation Engineer
3 weeks ago
Dublin, Ireland Tandem Project Management Ltd. Full timeOur client is a global biopharmaceutical company based in West Dublin, looking for a Senior Validation Engineer to complete and lead packaging validation activities end‑to‑end within aGMPenvironment, preparing the necessary documentation and ensuring audit‑ready records throughout the lifecycle. Typical project scope will include qualification and...
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QA Validation Engineer
3 weeks ago
Dublin, Ireland PE Global Full timeOverview The role: PE Global is currently recruiting a QA Validation Engineer for a permanent role, with a leading international manufacturing client based in Co. Westmeath. This is a full onsite role. Description: Provide Quality Assurance support to ensure the Quality System is of the highest standard with particular focus on validations and...
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Quality Validation Engineer
3 weeks ago
Dublin, Ireland PE Global Full timeOverview PE Global is currently recruiting a QA Validation Engineer for a permanent role, with a leading international manufacturing client based in Co. Westmeath This is a full onsite role. Provide Quality Assurance support to ensure the Quality System is of the highest standard with particular focus on validations and non-conformances. This position...
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Validation & Verification Engineer
3 weeks ago
Dublin, Ireland Embecta Full timeembecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and...
