Validation Engineer

Blackfield Associates; Munster; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Validation

GMP compliance

Documentation

Regulatory knowledge

Ausbildung

Bachelor's degree in Engineering

Pharma/biotech related

Tools

IQ/OQ/PQ protocols

Validation Master Plans

Jobbeschreibung

We are seeking an experienced Clean Utilities Validation Engineer to support qualification and validation activities within a GMP pharmaceutical manufacturing environment in Cork. The successful candidate will be responsible for ensuring that critical clean utility systems are designed, commissioned, qualified, and maintained in compliance with regulatory requirements and site quality standards.

Key Responsibilities

• Lead validation and qualification activities for clean utility systems including Purified Water (PW), Water for Injection (WFI), Clean Steam, Process Gases, Compressed Air, Nitrogen, and HVAC systems.
• Develop and execute Validation Master Plans (VMPs), Risk Assessments, IQ/OQ/PQ protocols, and final summary reports.
• Review engineering documentation including P&IDs, functional specifications, layout drawings, and vendor documentation.
• Support commissioning and qualification activities for new installations, upgrades, and facility expansions.
• Perform impact assessments, change controls, deviations, and CAPA investigations relating to validated systems.
• Coordinate validation activities with multidisciplinary project teams, contractors, and equipment vendors.
• Ensure compliance with GMP, FDA, EMA, MHRA, ISPE Baseline Guides, and EU GMP Annex 1 requirements.
• Review utility performance data and trending reports to verify ongoing state of control.
• Support internal and external audits and provide subject matter expertise during regulatory inspections.
• Assist in the implementation and continuous improvement of site validation strategies and procedures.

Required Experience

• Bachelor's Degree in Engineering, Pharmaceutical Sciences, Biotechnology, or a related discipline.
• Proven experience delivering validation and qualification activities within a pharmaceutical, biotechnology, or regulated manufacturing environment.
• Strong knowledge of clean utility systems including PW, WFI, Clean Steam, HVAC, Compressed Air, and Process Gases.
• Experience generating and executing IQ, OQ, and PQ documentation.
• Excellent understanding of GMP requirements and validation lifecycle principles.
• Experience supporting commissioning and qualification (C&Q) projects from design through operational handover.
• Strong documentation, analytical, and problem-solving skills