CQV Engineer

EFOR; Leinster; On-site; EUR 65,000 - 90,000; Full time

Job summary

EFOR is seeking an experienced CQV Engineer to lead commissioning, qualification and validation of laboratory equipment in GMP‑regulated pharma and biotech environments. The role emphasizes hands‑on implementation and documented compliance.

You will develop IQ/OQ/PQ protocols, coordinate FAT/SAT activities, and ensure alignment with project schedules and user requirements. Collaboration with quality, engineering and vendor teams is essential.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or related technical field.
• Minimum 3 years hands‑on experience in CQV for laboratory equipment within GMP‑regulated environments (pharma, biotech, etc.).
• Thorough understanding of applicable guidelines (FDA, EMA, ICH, USP, 21 CFR Part 11, GAMP 5, etc.).
• Proven ability to author and execute IQ, OQ, PQ protocols and related CQV documentation.
• Experience managing multiple projects and working with cross‑functional teams.

Responsibilities

• Lead and execute CQV activities for new and existing laboratory equipment (e.g., HPLC, GC, balances, incubators, centrifuges, autoclaves, spectrophotometers, etc.).
• Develop and review CQV documentation including commissioning plans, IQ/OQ/PQ protocols and reports, risk assessments, and traceability matrices.
• Coordinate equipment FAT/SAT, installation, and start‑up activities, ensuring alignment with project schedules and user requirements.
• Collaborate with laboratories, quality, compliance, engineering, and vendors during equipment selection, assessment, and qualification phases.
• Support change control, deviation management, and CAPA investigations related to lab equipment.
• Ensure all documentation meets current Good Manufacturing Practice (cGMP), regulatory, and company standards.
• Provide technical support and training to lab personnel regarding equipment operation and maintenance best practices.
• Track and report progress to project management and stakeholder teams.

Skills

CQV

GMP

Cross-functional teamwork

Project coordination

Troubleshooting

Communication

Education

Bachelor’s or Master’s degree in Engineering/Life Sciences

Tools

MS Office

Quality management systems

Electronic documentation platforms

Job description

We are seeking an experienced CQV Engineer with demonstrated expertise in commissioning, qualification, and validation of laboratory equipment for the pharmaceutical or biotech industry. The CQV Engineer will play a key role in ensuring lab equipment is installed and operates in compliance with industry and regulatory standards. This position requires hands‑on experience with a wide range of lab instruments, a solid understanding of GMP requirements, and the ability to work cross‑functionally.

Key Responsibilities:

• Lead and execute CQV activities for new and existing laboratory equipment (e.g., HPLC, GC, balances, incubators, centrifuges, autoclaves, spectrophotometers, etc.).
• Develop and review CQV documentation including commissioning plans, IQ/OQ/PQ protocols and reports, risk assessments, and traceability matrices.
• Coordinate equipment FAT/SAT, installation, and start‑up activities, ensuring alignment with project schedules and user requirements.
• Collaborate with laboratories, quality, compliance, engineering, and vendors during equipment selection, assessment, and qualification phases.
• Support change control, deviation management, and CAPA investigations related to lab equipment.
• Ensure all documentation meets current Good Manufacturing Practice (cGMP), regulatory, and company standards.
• Provide technical support and training to lab personnel regarding equipment operation and maintenance best practices.
• Track and report progress to project management and stakeholder teams.

Requirements:

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or related technical field.
• Minimum 3 years hands‑on experience in CQV for laboratory equipment within GMP-regulated environments (pharma, biotech, etc.).
• Thorough understanding of applicable guidelines (FDA, EMA, ICH, USP, 21 CFR Part 11, GAMP 5, etc.).
• Proven ability to author and execute IQ, OQ, PQ protocols and related CQV documentation.
• Experience managing multiple projects and working with cross‑functional teams.
• Strong troubleshooting, organizational, and communication skills.
• Proficiency in MS Office, and experience with quality management systems or electronic documentation platforms.