CSV Engineer: Validate & Optimize Regulated Systems

Recruitment by Aphex; Waterford; On-site; EUR 60,000 - 85,000; Full time

Job summary

Recruitment by Aphex is seeking a CSV Engineer to ensure validation compliance of computerized systems within a sterile pharmaceutical manufacturing environment. You will support the validation lifecycle, maintain regulatory compliance, and drive continuous improvement across manufacturing and support functions.

Responsibilities include creating and reviewing validation documents, executing DQ/IQ/OQ/PQ, participating in change control, and advising on CSV requirements in line with GMP and FDA/EU

Qualifications

• Degree in Science or Engineering or related discipline is required.
• Postgraduate qualification in validation, engineering, or pharmaceutical manufacturing is desirable.
• 3–5 years in healthcare, life sciences, or pharmaceutical manufacturing.
• 2–3 years in validation or computer systems validation roles.

Responsibilities

• Support validation of new computerized equipment and control systems.
• Generate and review validation documentation, including protocols and reports.
• Execute validation activities (DQ/IQ/OQ/PQ) and lifecycle management.
• Participate in change control and provide CSV guidance.
• Design and execute validation studies across manufacturing and utility systems.
• Ensure compliance with health and safety, cGMP, and regulatory requirements.
• Collaborate with Manufacturing, Engineering, Quality and other teams.
• Support inspections and audits as required.

Skills

CSV knowledge

Regulatory compliance

Change control

Documentation writing

Cross-functional collaboration

Project management

Analytical problem solving

Troubleshooting

Lifecycle management

Education

Degree in Science or Engineering

Postgraduate qualification relevant to validation

Job description

Recruitment by Aphex is seeking a CSV Engineer to ensure validation compliance of computerized systems within a sterile pharmaceutical manufacturing environment. You will support the validation lifecycle, maintain regulatory compliance, and drive continuous improvement across manufacturing and support functions.

Responsibilities include creating and reviewing validation documents, executing DQ/IQ/OQ/PQ, participating in change control, and advising on CSV requirements in line with GMP and FDA/EU