CSV Engineer

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

Purpose

The CSV Engineer plays a key role in ensuring the ongoing validation compliance of computerized systems and equipment within a sterile pharmaceutical manufacturing environment. The successful candidate will support the validation lifecycle of computerized systems, maintain compliance with regulatory requirements, and contribute to continuous improvement initiatives across manufacturing and support functions.

Responsibilities

• Support the validation of new computerized equipment, automation systems, and control systems.
• Generate and review validation documentation, including protocols and reports.
• Execute and support validation activities including DQ, IQ, OQ, and PQ.
• Participate in change control processes, providing guidance on Computer System Validation (CSV) requirements.
• Design, implement, and execute validation studies for manufacturing, utility, and control systems.
• Ensure validation activities comply with applicable health and safety, cGMP, environmental, and regulatory requirements.
• Maintain the validated state of computerized systems and equipment through effective lifecycle management.
• Support the development, review, execution, and approval of validation and revalidation plans.
• Review and approve change controls impacting validated systems.
• Provide technical support regarding current FDA, EU GMP, and industry validation requirements.
• Work cross-functionally with Manufacturing, Engineering, Quality, and other support departments to ensure compliance and project success.
• Support inspections and audits as required.

Requirements

• Degree in Science (Chemistry, Microbiology, Pharmacy, or related discipline) or Engineering (Chemical, Mechanical, Electrical, or related discipline).
• Desirable- Postgraduate qualification relevant to validation, engineering, or pharmaceutical manufacturing.
• 3 to 5 years' experience within a healthcare, life sciences, or pharmaceutical manufacturing environment.
• 2 to 3 years' experience in a validation or computer systems validation role.
• Experience managing or supporting technical projects in a regulated environment.
• Experience working with computerized systems used in manufacturing operations.
• Strong understanding of Computer System Validation (CSV) principles and lifecycle management.
• Knowledge of GAMP, ISPE guidance documents, and industry best practices.
• Good understanding of cGMP requirements and pharmaceutical compliance regulations.
• Ability to troubleshoot validation-related issues and drive effective solutions.
• Knowledge of pharmaceutical manufacturing processes and equipment.
• Familiarity with quality management systems, change control, and deviation management.
• Strong project planning and execution skills.
• Effective communication and stakeholder management skills.
• Ability to work independently and collaboratively within cross-functional teams.
• Strong team player with the ability to influence and collaborate across departments.
• Self-motivated, resilient, and results-oriented.
• Adaptable and flexible in a fast-paced regulated environment.
• Pragmatic problem solver with strong analytical skills.
• Ability to manage multiple priorities and deliver projects to completion.
• This role operates within a GMP-regulated pharmaceutical manufacturing facility and requires close collaboration with Manufacturing, Engineering, Quality, Validation, and other support functions to ensure ongoing compliance and operational excellence.