CSV Engineer Belgium

Resourcing Life Science; Town of Belgium (WI); On-site; USD 80,000 - 100,000; Full time

Job summary

A company in the life sciences sector located in Wisconsin is seeking a professional with extensive experience in managing GxP IT systems and performing Computer Systems Validation. Responsibilities include risk identification, handling compliance procedures, and supporting regulatory audits. Ideal candidates will possess a strong background in IT infrastructure and a higher education qualification in a related technical field.

Qualifications

• Experience within a Pharmaceutical or Life Science environment is essential.
• In-depth knowledge of GAMP 5 and Data Integrity regulations.

Responsibilities

• Identify and mitigate risks for GxP IT systems.
• Prepare and execute core CSV deliverables.
• Manage Corrective and Preventive Actions (CAPAs).
• Serve as the subject matter expert for CSV during audits.

Skills

Proven professional experience in regulated GxP environment

Extensive background in Computer Systems Validation

Strong understanding of IT Infrastructure and Networks

Practical knowledge of IT Qualification (IQ) activities

Education

Higher education qualification in Computer Science or related discipline

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]