On-Site QA Validation Specialist: Utilities (Pharma)

R Dpartners; Cashel; On-site; EUR 76,000 - 90,000; Full time

Job summary

R Dpartners in Cashel seeks a QA Validation Specialist for a site-based contract role, focusing on utilities validation across HVAC, WFI, steam, and related systems. You will ensure QA oversight, qualification activity alignment with regulatory expectations, and collaboration with engineering and quality teams to maintain GMP compliance.

The role requires a science/engineering degree and at least five years in a GMP pharmaceutical or biopharma environment, with strong documentation and

Qualifications

• Degree in a scientific or engineering discipline.
• Minimum 5 years in a GMP-regulated pharmaceutical or biopharmaceutical environment.
• Proven validation experience for utility systems (HVAC, WFI, clean steam, gases).
• Strong knowledge of validation lifecycle and regulatory expectations (HPRA, FDA).
• Excellent documentation and communication skills.

Responsibilities

• Review and approve qualification and validation documentation (IQ/OQ/PQ) for utility systems.
• Provide QA oversight during validation activities related to utilities and facility systems.
• Support SVMP development with a focus on utility systems.
• Collaborate with engineering and maintenance to ensure compliant validation of utilities.
• Lead or support investigations into deviations and drive CAPAs.
• Review calibration and preventive maintenance records for utility equipment.
• Participate in risk assessments and technical studies impacting validated state.
• Assist audits as SME for utility validation.

Skills

Validation of utility systems

GMP experience

Documentation & communication

Education

Science or Engineering degree

Job description

R Dpartners in Cashel seeks a QA Validation Specialist for a site-based contract role, focusing on utilities validation across HVAC, WFI, steam, and related systems. You will ensure QA oversight, qualification activity alignment with regulatory expectations, and collaboration with engineering and quality teams to maintain GMP compliance.

The role requires a science/engineering degree and at least five years in a GMP pharmaceutical or biopharma environment, with strong documentation and