Senior Validation Engineer – Clean Utilities (GMP)

Blackfield Associates; Munster; On-site; EUR 60,000 - 85,000; Full time

Job summary

Blackfield Associates is seeking an experienced Clean Utilities Validation Engineer in Cork, Ireland. The role focuses on leading validation and qualification of PW, WFI, Clean Steam, HVAC, and gases in a GMP manufacturing setting.

You will develop VMPs, perform risk assessments, compile IQ/OQ/PQ protocols and final reports, and review P&IDs, specs, and vendor documents. Strong GMP knowledge and regulatory familiarity are essential.

Qualifications

• Bachelor's degree in engineering or related field.
• Proven experience delivering validation and qualification activities in pharma/regulatory manufacturing.
• Strong knowledge of clean utilities including PW, WFI, Clean Steam, HVAC, compressed air and process gases.
• Experience generating and executing IQ, OQ and PQ documentation.

Responsibilities

• Lead validation and qualification activities for clean utility systems including PW, WFI, Clean Steam, process gases, compressed air, nitrogen and HVAC.
• Develop and execute Validation Master Plans (VMPs), risk assessments, IQ/OQ/PQ protocols and final reports.
• Review engineering docs such as P&IDs, functional specs, layout drawings and vendor docs.
• Support commissioning and qualification for new installations, upgrades and expansions.
• Perform impact assessments, deviations, CAPA investigations related to validated systems.
• Coordinate validation activities with project teams, contractors and vendors.
• Ensure compliance with GMP, FDA, EMA, MHRA, ISPE Baseline Guides and EU GMP Annex 1.
• Review utility performance data and trending to verify state of control.
• Support internal and external audits and regulatory inspections.
• Assist in implementing and improving validation strategies and procedures.

Skills

Validation

GMP compliance

Documentation

Regulatory knowledge

Education

Bachelor's degree in Engineering

Pharma/biotech related

Tools

IQ/OQ/PQ protocols

Validation Master Plans

Job description

Blackfield Associates is seeking an experienced Clean Utilities Validation Engineer in Cork, Ireland. The role focuses on leading validation and qualification of PW, WFI, Clean Steam, HVAC, and gases in a GMP manufacturing setting.

You will develop VMPs, perform risk assessments, compile IQ/OQ/PQ protocols and final reports, and review P&IDs, specs, and vendor documents. Strong GMP knowledge and regulatory familiarity are essential.