C&Q Engineer

Ellab; Munster; On-site; EUR 90,000 - 130,000; Full time

Job summary

Ellab is seeking an experienced C&Q Engineer based in Kerry to lead commissioning, qualification, and validation activities for GMP facilities and related systems. The role focuses on developing and executing commissioning plans, IQ, OQ, and PQ protocols, risk assessments, and comprehensive summary reports.

The ideal candidate will have a Bachelor’s degree in Engineering or a related discipline and at least 5 years of CQ/validation experience within pharmaceutical or life sciences sectors, with

Qualifications

• Bachelor’s degree in Engineering, Science, or related discipline.
• 5+ years of C&Q/validation experience in pharmaceutical/biotech/life sciences industries.
• Strong knowledge of GMP regulations and validation lifecycle principles.
• Experience with clean utilities, HVAC, manufacturing equipment, and automation systems.
• Excellent technical writing, communication, and stakeholder management skills.

Responsibilities

• Commissioning and qualification activities for facilities, utilities, process equipment, and manufacturing systems.
• Develop and execute Commissioning Plans, IQ, OQ, PQ protocols, risk assessments, and summary reports.
• Coordinate vendors, contractors, and cross-functional teams during project execution.
• Ensure compliance with GMP, GDP, ISPE Baseline Guides, ASTM E2500, and applicable regulatory requirements.
• Review and approve engineering and validation documentation.
• Troubleshoot commissioning and qualification issues and drive timely resolution.
• Support audits, inspections, and regulatory inquiries.

Skills

CQ/validation experience

GMP knowledge

Technical writing

Stakeholder management

Education

Bachelor’s degree in Engineering/Science

Tools

HVAC systems

Automation systems

Job description

Exciting new role based in Kerry, er are looking for an experienced C&Q Engineer who has experience in developing and executing Commissioning Plans, IQ, OQ, PQ protocols, risk assessments, and summary reports.

The C&Q Engineer is responsible for planning, executing, documenting, and leading commissioning, qualification, and validation activities for GMP facilities, utilities, equipment, and computerized systems within regulated pharmaceutical and biotechnology environments.

Key Responsibilities

• Commissioning and qualification activities for facilities, utilities, process equipment, and manufacturing systems.
• Develop and execute Commissioning Plans, IQ, OQ, PQ protocols, risk assessments, and summary reports.
• Coordinate vendors, contractors, and cross-functional teams during project execution.
• Ensure compliance with GMP, GDP, ISPE Baseline Guides, ASTM E2500, and applicable regulatory requirements.
• Review and approve engineering and validation documentation.
• Troubleshoot commissioning and qualification issues and drive timely resolution.
• Support audits, inspections, and regulatory inquiries.

Required Qualifications

• Bachelor’s degree in Engineering, Science, or related discipline.
• 5+ years of C&Q/validation experience within pharmaceutical, biotech, medical device, or life sciences industries.
• Strong knowledge of GMP regulations and validation lifecycle principles.
• Experience with clean utilities, HVAC, manufacturing equipment, and automation systems.
• Excellent technical writing, communication, and stakeholder management skills.

Desirable Experience

• Experience with sterile, aseptic, or biologics manufacturing facilities.
• Knowledge of computerized systems validation (CSV/CSA).
• Project leadership and mentoring experience.
• Familiarity with risk-based validation approaches and digital validation tools.