CSV Engineer (Computer System Validation)

Job Title: CSV Engineer (Computer System Validation)

About the Role

We are seeking a highly skilled CSV Engineer to join our team and ensure compliance of computer systems with regulatory standards. The successful candidate will play a key role in validating GxP systems, supporting audits, and maintaining documentation in line with industry best practices.

What You’ll Do

* Validation Lifecycle Management: Lead the validation of GxP-impactful systems, including ERP, LIMS, QMS, and automated manufacturing equipment.

* Risk Assessment: Identify potential pitfalls in system workflows and develop mitigation strategies to maintain data integrity.

* Documentation Excellence: Author and execute Validation Plans, Protocols (IQ/OQ/PQ), and Summary Reports.

* Audit Readiness: Act as the subject matter expert (SME) during internal and external audits, confidently defending validation strategies.

* Continuous Improvement: Monitor system performance and manage Change Controls to ensure the validated state is maintained throughout the system's life.

What You Bring

* Expertise: Deep understanding of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.

* Experience: 3+ years in a regulated industry (Life Sciences, Biotech, or Pharma preferred).

* Technical Savvy: Ability to translate technical software specs into clear validation requirements.

* Precision: An eagle eye for detail and a "do it right the first time" mentality.