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.