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, L2–L4 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 *****, 21 CFR Parts *******, 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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