Validation Engineer
3 weeks ago
Are you an experienced Validation Engineer looking for your next challenge? We are currently hiring an Engineering Specialist (Validation) to join a leading biopharmaceutical company at their state-of-the-art Carlow site. This is a fantastic opportunity to work in a dynamic and fast-paced cGMP regulatory environment, supporting critical validation activities in sterile manufacturing.
About the Role:The successful candidate will be responsible for executing and supporting validation processes across multiple areas, including:
- Sterilisation - Autoclaves, SIP of vessels
- Cleaning Validation - Parts Washer and CIP of vessels
- Isolators - HVAC, VHP, E-Beam, Depyrogenation
- Controlled Temperature Units (CTU) - Temperature/Humidity Mapping
- Filter Validation & Container Closure Integrity Validation
- Author, review, approve, and execute qualification/validation documentation and cycle development studies.
- Lead change controls and resolve technical issues during study execution.
- Perform root cause analysis for system failures and drive continuous improvement using Lean Six Sigma methodologies.
- Act as the validation representative for cross-functional projects and technical forums.
- Support regulatory audits and ensure compliance with cGMP standards.
- Provide technical input into investigations and risk assessments.
- Work collaboratively with Production, Quality, and Maintenance teams to optimize validation processes.
- Relevant degree in Applied Pharmaceutical/Biological/Chemical Sciences, Technical/Engineering fields.
- Proven track record in validation within a GMP manufacturing environment.
- Experience with thermal mapping, exception/deviation management, and change control.
- Strong ability to analyze complex data and link findings to equipment performance.
- Knowledge of automation systems (DeltaV), process monitoring, and operational intelligence systems (Pi System) is advantageous.
- Excellent communication, problem-solving, and project management skills.
Work with a leading biopharmaceutical company in an advanced GMP facility.
Be part of a collaborative, innovative, and high-performance environment.
Competitive salary and opportunities for professional growth.
The Next Step for YouShould this position be of interest, please apply through LinkedIn with an up-to-date CV to Jessica from Next Generation Recruitment or call us on the main line at 016629120.
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