QA Validation Engineer

4 weeks ago

Cork, Cork, Ireland Hobson Prior Full time
QA Validation Specialist – Pharmaceuticals, Biotech

Hobson Prior is seeking a QA Validation Specialist to support the qualification and validation of equipment, computerised systems, facilities, and utilities in a regulated pharmaceutical environment. This role is critical in ensuring compliance with GMP standards and maintaining a validated state across site operations. The successful candidate will work cross-functionally with engineering, production, and quality teams to support ongoing and project-based validation activities.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities
  • Review and approve qualification and validation documentation (IQ/OQ/PQ) for equipment, systems, facilities, and utilities.
  • Provide QA oversight during execution of qualification, requalification, and validation activities.
  • Develop and maintain the Site Validation Master Plan (SVMP) in alignment with regulatory expectations and internal policies.
  • Generate and execute project-specific validation plans and validation master plans.
  • Coordinate with manufacturing and engineering teams to ensure timely and compliant completion of validation tasks.
  • Lead or support investigations into deviations or deficiencies related to qualification activities, and drive corrective and preventive actions (CAPAs).
  • Prepare and review SOPs, protocols, reports, and technical drawings related to validation.
  • Review and approve calibration and preventive maintenance schedules and associated work orders.
  • Conduct and support risk assessments, technical studies, and investigations impacting the validated state.
  • Participate in audits and inspections, providing subject matter expertise on validation-related topics.
Qualifications & Experience
  • Degree in a scientific discipline (e.g., Chemistry, Biology, Engineering).
  • Proven working years in a GMP-regulated pharmaceutical or biopharmaceutical environment.
  • Strong working knowledge of validation lifecycle principles, including IQ/OQ/PQ.
  • Experience with Site Validation Master Plan development and maintenance.
  • Familiarity with HPRA and FDA regulatory requirements.
  • Excellent documentation, communication, and cross-functional collaboration skills.

For more information, please contact Billy O\'Brien.

If you are interested in applying to this exciting opportunity, then please click Apply or visit the Contact Us page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you\'ve read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.hobsonprior.com/privacy-policy.


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