Join a dynamic pharmaceutical company on a contract basis during a pivotal phase of growth and commercial readiness.
We are seeking a QA Validation Specialist with specific expertise in utilities validation (e.g., HVAC, purified water, compressed air, steam systems) to support qualification and validation activities across site operations. The successful candidate will provide quality oversight and ensure compliance with regulatory standards, working closely with engineering, facilities, and quality teams.
Please note that this is an on-site position in Cashel. To be considered for this role you must have the right to work in this location.
Responsibilities:
- Review and approve qualification and validation documentation (IQ/OQ/PQ) specifically for utility systems.
- Provide QA oversight during execution of validation activities related to utilities and facility systems.
- Support the development and maintenance of the Site Validation Master Plan (SVMP) with a focus on utility systems.
- Collaborate with engineering and maintenance teams to ensure timely and compliant validation of new and existing utilities.
- Lead or support investigations into deviations or deficiencies related to utility qualification, and drive CAPAs.
- Review and approve calibration and preventive maintenance records for utility-related equipment.
- Participate in risk assessments and technical studies impacting the validated state of utility systems.
- Support internal and external audits, acting as SME for utility validation.
Key Skills and Requirements:
- Degree in a scientific or engineering discipline (e.g., Mechanical Engineering, Chemical Engineering, Life Sciences).
- Minimum 5 years of experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.
- Proven experience in validation of utility systems (e.g., HVAC, WFI, clean steam, compressed gases).
- Strong understanding of validation lifecycle principles and regulatory expectations (HPRA, FDA).
- Excellent documentation and communication skills.
- Ability to work independently and collaboratively in a cross-functional team.
Salary:
- €55.00 - €65.00/Hour
For more information, please contact Billy O'Brien.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.
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