C&Q Engineer

Ellab; Munster; On-site; EUR 70,000 - 110,000; Full time

Job summary

Ellab in Kerry, Ireland, is seeking an experienced C&Q Engineer to plan, execute, and lead commissioning, qualification, and validation activities for GMP facilities and related systems. The role covers IQ, OQ, PQ protocols, risk assessments, and summary reports, with cross-functional coordination of vendors and contractors.

You will ensure compliance with GMP, GDP, ISPE Baseline Guides, ASTM E2500, and regulatory requirements, review documentation, and mentor project teams, while addressing

Qualifications

• Bachelor’s degree in Engineering, Science, or related discipline.
• 5+ years of C&Q/validation experience in pharma/biotech/life sciences.
• Strong knowledge of GMP regulations and validation lifecycle.
• Experience with clean utilities, HVAC, manufacturing equipment, and automation systems.
• Experience with sterile, aseptic, or biologics facilities.
• Knowledge of computerized systems validation (CSV/CSA).
• Excellent writing and communication; stakeholder management.
• Project leadership and mentoring experience.
• Familiarity with risk-based validation approaches and digital validation tools.

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

Technical writing

Communication

Stakeholder management

Project leadership

Mentoring

Risk-based validation

Digital validation tools

Education

Bachelor's degree in Engineering/Science

Tools

CSV/CSA

GMP software tools

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.
• 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.