CQV Engineer (Junior) — Sterile Fill-Finish GMP Projects

Ascend Project Management; South Dublin; On-site; EUR 60,000 - 85,000; Full time

Job summary

AscendPM is partnering with a leading life sciences company in South Dublin to recruit a Junior CQV Engineer on a 12-month contract. The role supports equipment, capital projects and clean utilities across the validation lifecycle, with emphasis on sterile fill-finish environments.

The successful candidate will lead CQV activities, develop qualification strategies, coordinate activities across multidisciplinary teams, and ensure compliance with GMP and regulatory standards throughout project

Qualifications

• Minimum 6 years of experience in Commissioning, Qualification & Validation within pharmaceutical/biotech sectors.
• Experience managing CQV activities across capital projects and equipment lifecycles.
• Strong understanding of GMP and regulatory requirements.

Responsibilities

• Lead and provide technical CQV support across the full validation lifecycle, from design to qualification and ongoing validation maintenance.
• Develop and execute risk-based qualification strategies for equipment and clean utilities (URSs, V&V plans, FATs, SATs, IOQs, PQs).
• Coordinate qualification activities to keep systems validated and compliant throughout their lifecycle.
• Support sterile manufacturing systems qualification including vial/syringe filling and clean utilities.
• Collaborate with Engineering, Manufacturing, Quality and external vendors to align with Quality by Design principles.

Skills

CQV

Validation

GMP

Regulatory

Quality

Sterile manufacturing

Education

Engineering or Science degree

Job description

AscendPM is partnering with a leading life sciences company in South Dublin to recruit a Junior CQV Engineer on a 12-month contract. The role supports equipment, capital projects and clean utilities across the validation lifecycle, with emphasis on sterile fill-finish environments.

The successful candidate will lead CQV activities, develop qualification strategies, coordinate activities across multidisciplinary teams, and ensure compliance with GMP and regulatory standards throughout project