CQV Engineer

EFOR; Athlone; On-site; EUR 90,000 - 130,000; Full time

Job summary

EFOR is seeking a highly skilled CQV Engineer with strong process engineering experience in cGMP-regulated biopharmaceutical or pharmaceutical manufacturing. The role focuses on leading commissioning, qualification, and validation activities for process equipment and systems essential to commercial manufacturing.

The ideal candidate has 5+ years of CQV experience, sterile/fill-finish exposure, and familiarity with FDA/EMA/ICH guidelines.

Qualifications

• 5+ years CQV engineering experience in a cGMP biopharmaceutical or pharmaceutical manufacturing environment.
• Commercial drug product manufacturing experience; sterile/fill-finish operations strongly preferred.
• Familiarity with FDA, EMA, ICH, ISPE guidelines for pharmaceutical manufacturing.
• Strong problem-solving, documentation, and analytical skills.
• Excellent communication and interpersonal abilities.
• Ability to work in a fast-paced, collaborative environment.

Responsibilities

• Lead and execute commissioning, qualification, and validation activities for process equipment and systems (sterile/fill-finish lines, packaging, utilities, automation).
• Develop and review CQV documentation (URS, FRS, DQ, IQ, OQ, PQ protocols and reports) per cGMP standards.
• Support commercial drug product manufacturing operations and troubleshoot equipment and process issues.
• Collaborate with cross-functional teams (Manufacturing, QA, Engineering, Maintenance, Project Management).
• Participate in risk assessments, process mapping, and change control activities for equipment and processes.
• Ensure CQV activities comply with regulatory expectations and industry best practices.
• Provide technical process engineering support to optimize manufacturing and ensure compliance.
• Mentor and guide junior engineers and technicians involved in CQV and process support.

Skills

CQV engineering

Problem solving

Documentation

Analytical skills

Communication

Interpersonal skills

Team collaboration

Education

Bachelor’s degree in Chemical/Mechanical Engineering or related STEM field

Job description

Position Overview:

We are seeking a highly skilled CQV Engineer with strong process engineering experience in cGMP-regulated biopharmaceutical or pharmaceutical manufacturing. The ideal candidate will have hands-on expertise supporting commercial drug product manufacturing, with a strong preference for exposure to sterile/fill-finish operations. In this role, you will lead commissioning, qualification, and validation activities for process equipment and systems integral to commercial manufacturing operations.

Key Responsibilities:

• Lead and execute commissioning, qualification, and validation (CQV) activities for process equipment and systems (sterile/fill-finish lines, packaging, utilities, automation, etc.).
• Develop and review CQV documentation (URS, FRS, DQ, IQ, OQ, PQ protocols and reports) in alignment with cGMP standards and site procedures.
• Support commercial drug product manufacturing operations and troubleshoot equipment and process issues.
• Collaborate with cross-functional teams (Manufacturing, Quality Assurance, Engineering, Maintenance, Project Management).
• Participate in risk assessments, process mapping, and change control activities for equipment and processes.
• Ensure CQV activities comply with regulatory expectations and industry best practices.
• Provide technical process engineering support to optimize manufacturing and ensure compliance.
• Mentor and guide junior engineers and technicians involved in CQV and process support.

Qualifications & Experience:

• Bachelor’s degree (or higher) in Chemical Engineering, Mechanical Engineering, or related STEM field.
• Over 5 years CQV engineering experience in a cGMP biopharmaceutical or pharmaceutical manufacturing environment.
• Proven track record in commercial drug product manufacturing; sterile/fill-finish operations experience strongly preferred.
• Familiarity with regulatory guidelines (FDA, EMA, ICH, ISPE) for pharmaceutical manufacturing.
• Strong problem-solving, documentation, and analytical skills.
• Excellent communication and interpersonal abilities.
• Ability to work in a fast-paced, collaborative environment.