Systems Validation Engineer
We are looking for a resource to help our Computer System Validation team that I run. It would need to be someone with R&D IT experience and understanding of 21CFR11 and Annex 11 as our applications are global.
Title: Computer System Validation (CSV) Specialist
Location: Remote, Hybrid
Department: IT – R&D
Job Description:
We are seeking a detail-oriented and experienced Computer System Validation (CSV) Specialist to join our global team supporting R&D IT operations. The ideal candidate will have hands-on experience in CSV within the pharmaceutical or life sciences industry, with a strong understanding of regulatory requirements including 21 CFR Part 11 and Annex 11. You will play a key role in ensuring that our R&D systems meet compliance standards, both from a technical and quality assurance perspective, across our global applications.
Key Responsibilities:
- Lead the validation of computer systems to ensure compliance with 21 CFR Part 11, Annex 11, and other relevant regulations.
- Collaborate with cross-functional teams to define, execute, and document validation activities (IQ/OQ/PQ).
- Perform risk assessments, gap analyses, and determine validation requirements for R&D IT systems.
- Develop and review validation documentation including validation plans, protocols, reports, and traceability matrices.
- Provide guidance and support to the global team on regulatory and quality compliance for IT systems.
- Ensure the maintenance of validated states for critical applications and systems.
- Assist in identifying and managing non-compliance issues, proposing remediation actions when needed.
Qualifications:
- Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or related field.
- Minimum of [X] years of experience in Computer System Validation, specifically with R&D IT systems.
- In-depth knowledge of 21 CFR Part 11, Annex 11, and other applicable regulatory guidelines.
- Strong experience with validation documentation and risk-based approaches.
- Familiarity with global regulatory compliance requirements for software and systems in a regulated environment.
- Excellent communication and collaboration skills to work with internal and external teams.
Preferred:
- Experience with global R&D systems, including LIMS, laboratory systems, or clinical trial management systems (CTMS).
- Familiarity with validation tools and automated validation techniques.
Application Process:
Interested candidates should submit a resume and cover letter outlining their experience with regulatory compliance in IT systems.