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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
Key Responsibilities:
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.
What You Need to Succeed:
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.
Why Apply?
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 You
Should 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.
Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical, and Operation positions (permanent, contract, and temporary). All applications are handled in strict confidence. We never share your data outside of our organization without your prior written consent.
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