C&Q Engineer

ELLAB A/S; Hillerød; On-site; DKK 523,000 - 710,000; Full time

Job summary

ELLAB A/S in Ireland is seeking an experienced C&Q Engineer to lead commissioning, qualification, and validation activities for GMP facilities, utilities, equipment, and computerized systems.

You will develop and execute Commissioning Plans, IQ/OQ/PQ protocols, risk assessments, and summary reports while coordinating vendors, contractors, and cross-functional teams to ensure regulatory compliance and timely project delivery.

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.

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

C&Q/validation experience

GMP regulations knowledge

Technical writing

Stakeholder management

Education

Bachelor's degree in Engineering/Science

Tools

CSV/CSA

Validation lifecycle 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.

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.

Lokation: Ireland