Validation Engineer - Pharmaceutical Industry
Lead validation innovation at a premier biotech facility.
Join a dynamic team at our state-of-the-art site in Carlow, Ireland - a key manufacturing center producing critical pharmaceutical products during an exciting expansion phase. As a Validation Engineer, you'll spearhead equipment, process, and system qualifications to uphold the highest compliance standards. Reporting to the Validation Manager, apply your technical expertise to drive seamless method transfers, IQ/OQ/PQ, and lifecycle management in a high-impact role.
Key Benefits of the Role
- Collaborative culture: Partner with high-performing teams focused on safety, cGMP compliance, and cutting-edge engineering.
- Strategic impact: Enable reliable production of essential medicines through robust validation strategies.
Core Responsibilities
- Plan, execute, and document validation activities for equipment, utilities, facilities, and processes (IQ/OQ/PQ).
- Lead analytical method transfers, validations, and verifications in line with cGMP and regulatory guidelines.
- Perform risk assessments (e.g., FMEA) and root cause analysis for deviations, change controls, and CAPAs.
- Author and review validation protocols, reports, SOPs, and technical documentation ensuring data integrity.
- Support audits/inspections as SME, maintaining site readiness and Right First Time KPIs.
- Drive continuous improvement in validation systems using tools like 5 Whys and Fishbone diagrams.
- Collaborate cross-functionally to integrate validation into manufacturing operations.
Qualifications We Value
- Bachelor's degree or higher (ideally in Engineering, Chemistry, or Life Sciences).
- 2-3+ years in pharmaceutical validation, with hands-on IQ/OQ/PQ and cGMP experience.
- Proficiency in validation software/tools, LIMS, and regulations (FDA, EMA).
- Desired: Biologics/vaccines validation, method transfer, and clean utilities experience.
The Next Step for you:
Should this position be of interest to you please forward your CV from Next Generation Recruitment or apply on our website.
Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.
Applications are in strict confidence.
Next Generation will never share your data outside of our organisation without your prior written consent.
