CQV Validation Engineer - Sterile Fill & Utilities

Arcadis; Leinster; On-site; EUR 85,000 - 115,000; Full time

Job summary

Arcadis Ireland is seeking a Commissioning, Qualification and Validation (CQV) Engineer to join a dynamic team on capital projects and equipment/clean utilities lifecycles. You will lead validation activities to ensure GMP compliance, quality-by-design principles, and safe, on-schedule delivery.

Experience with sterile fill-finish systems and regulatory inspections is highly valued. The role requires collaboration across engineering, manufacturing, QA, and external vendors to develop URS,

Qualifications

• 6+ years' experience in Engineering, Validation, Commissioning, Qualification, or a related scientific discipline.
• Third-level qualification in Engineering or Science.
• Extensive knowledge managing Commissioning and Qualification activities for pharmaceutical or biotechnology projects.
• Strong understanding of risk-based commissioning and qualification approaches in regulated environments.
• Experience with sterile manufacturing equipment preferred.
• Knowledge of GMP and regulatory requirements.
• Ability to work in multidisciplinary project teams and support investigations.

Responsibilities

• Provide expert validation support across the full lifecycle from design through qualification to validation maintenance.
• Coordinate qualification activities and maintain equipment and utility systems in a validated state.
• Develop qualification approaches and equipment family strategies.
• Assist in developing URSs and Quality Risk Assessments for Equipment and Automated Systems.
• Develop and approve C&Q/Validation Plans, FAT, SAT, IOQs and PQs for vial/syringe filling, formulation, and clean utilities.
• Assess project change controls to ensure validation standards are met.
• Liaise with Engineering, CQV, Manufacturing, Planning, Process Development, and external vendors.
• Contribute to continuous improvement of validation lifecycle processes and regulatory readiness.
• Participate in regulatory inspections and filings as required.
• Update SOPs in line with site and corporate requirements.

Skills

Validation

Commissioning

Qualification

GMP compliance

Regulatory knowledge

Sterile manufacturing

Risk-based approach

Multidisciplinary teamwork

Education

Third-level degree in Engineering or Science

Tools

URS development

QRAES

FAT/SAT

PQ/IQ/OQ

Job description

Arcadis Ireland is seeking a Commissioning, Qualification and Validation (CQV) Engineer to join a dynamic team on capital projects and equipment/clean utilities lifecycles. You will lead validation activities to ensure GMP compliance, quality-by-design principles, and safe, on-schedule delivery.

Experience with sterile fill-finish systems and regulatory inspections is highly valued. The role requires collaboration across engineering, manufacturing, QA, and external vendors to develop URS,