Job Title:
CSV Engineer (Computer System Validation)
Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below.
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. xjsrcvq Precision:
An eagle eye for detail and a "do it right the first time" mentality.