CSV Engineer Ireland

Resourcing Life Science; Ireland; On-site; EUR 50,000 - 80,000; Full time

Job summary

A leading life science consultancy based in Ireland is seeking a professional with strong expertise in Computer Systems Validation (CSV) to identify and manage risks associated with GxP IT systems. The ideal candidate will have experience in pharmaceutical or similarly regulated environments and will demonstrate technical skill in preparing CSV deliverables. This role involves working closely with IT and process owners to enhance compliance through effective risk management and continuous improvement initiatives.

Qualifications

• Experience in Pharmaceutical or Life Science regulated environments.
• Practical knowledge of IT Qualification (IQ) activities.
• Familiarity with GAMP 5.

Responsibilities

• Identify and mitigate risks in GxP IT systems.
• Prepare and execute validation protocols and reports.
• Provide support for compliance and quality deviations.

Skills

GxP compliance

Computer Systems Validation (CSV)

IT Infrastructure knowledge

Data Integrity regulations

Education

Higher education in Computer Science or related field

Job description

Responsibilities

• Work with relevant Change Owners for all GxP IT systems to identify and mitigate risks, ensuring all changes are tracked to completion.
• Prepare and execute core CSV deliverables, including validation protocols, summary reports, and periodic system reviews.
• Provide technical assessment and system support for quality deviations and non-conformances.
• Recommend and manage Corrective and Preventive Actions (CAPAs) to enhance system compliance and performance.
• Author and maintain SOPs and work instructions governing the operation, maintenance, and compliance of software systems.
• Collaborate with IT and process owners to ensure the compliance of software systems throughout the entire system lifecycle.
• Ensure adherence to CSV procedures during system implementations and provide support for new software projects, including updates to the validation master plan.
• Serve as the subject matter expert for CSV during internal and external regulatory audits.
• Coordinate with the Validation department to align CSV processes with broader site validation policies and standards.
• Research and propose the implementation of new technologies to improve business and compliance processes.

Key Requirements

• Proven professional experience within a Pharmaceutical, Life Science, or similarly regulated GxP environment.
• Extensive background in Computer Systems Validation (CSV) or a higher education qualification in Computer Science or a related technical discipline.
• Strong understanding of IT Infrastructure and Networks.
• Practical knowledge of IT Qualification (IQ) activities and documentation.
• Familiarity with industry standards such as GAMP 5 and Data Integrity regulations.

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email [e-mail]