Commissioning Engineer - CQV

Next Generation Recruitment; Ireland; On-site; EUR 120,000 - 144,000; Part time

Job summary

Next Generation Recruitment in Dublin is seeking a qualified CQV engineer to prepare and execute site commissioning and validation testing for sterile drug product equipment and utilities.

You will work with the Area CQV Lead, ensure GMP compliance, document CQV activities, and manage risks and deviations across the project, with a 5-6 month contract.

Qualifications

• BS degree in a scientific, technical, or engineering discipline.
• 5+ years' pharmaceutical industry experience, sterile drug product familiarity preferred.
• Proven CQV testing approach from initiation to completion.
• CQV lifecycle experience from design through C&Q and handover.
• Experience in CQV for drug substance/drug product sterile equipment with automation.
• Strong document preparation and planning on CQV projects.

Responsibilities

• Develop and execute CQV testing documentation for benchtop equipment and inspection booths.
• Meet key project deliverables for safety, CQV schedule, and project records.
• Ensure GMP equipment testing complies with EU/FDA regulations.
• Ensure equipment testing aligns with project standards from commissioning perspective.
• Manage deviations associated with equipment and utilities.
• Identify CQV risks and generate mitigation action plans.
• Perform FAT testing and integrate results into qualification process.
• Complete training on time to meet site metrics.

Skills

CQV testing

GMP compliance

Documentation

Communication skills

Team collaboration

Electronic validation platforms (ValV,

Education

BS degree in scientific/technical/engineering

Tools

ValGenesis

Kneat

Job description

Location: Dublin (fully on-site role)
Contract: 5-6 Months

Rate: €75.00 per hour

Job Function

Working in association with the Area CQV Lead, prepare and execute site commissioning and validation testing for equipment and utilities at a sterile drug product manufacturing facility, in alignment with site and global procedures.

Responsibilities

• Develop and execute CQV testing documentation for benchtop equipment and manual inspection booths within the sterile drug product facility.
• Meet key project deliverables for safety, CQV schedule, and quality of project-related documentation and electronic records for assigned equipment and utilities.
• Ensure GMP equipment is tested in compliance with good manufacturing practices, company policies, and EU & FDA regulations.
• Ensure all equipment is tested in compliance with relevant project standards from a commissioning perspective.
• Manage deviations associated with assigned equipment and utilities.
• Identify and categorise CQV risks according to their impact on commissioning and qualification; generate action plans to mitigate qualification risks.
• Execute FAT testing and leverage results into the overall qualification process for assigned equipment, facilities, and utilities.
• Complete all assigned training on time to meet site metrics.

Required Qualifications and Experience

• Minimum of a BS (Degree) in a scientific, technical, or engineering discipline.
• Minimum of 5 years' experience within the pharmaceutical industry, ideally with familiarity in sterile drug product filling line experience.
• Demonstrable capacity to effectively execute the CQV testing approach for assigned equipment, from initiation to completion.
• CQV project lifecycle experience, from design through to C&Q and handover.
• Demonstrable experience working as part of a diverse team of CQV professionals and contractors, delivering tasks safely, on time, within budget, and with a strong quality focus.
• Experience in CQV of drug substance/drug product sterile manufacturing equipment with integrated automation.
• Solid background in document preparation, execution, and task planning on CQV projects, with a demonstrated record of on-time delivery.
• Excellent communication skills and the ability to influence others.
• Demonstrable experience working in teams within a matrix environment to deliver CQV elements.
• Previous experience with an electronic validation platform (e.g. ValGenesis, Kneat) is desirable.