Computer System Validation Engineer

About the role

ProPharma, a consultancy serving biotech, medical device and pharmaceutical organisations, is hiring a Computer System Validation Engineer. The role covers the full life cycle of computer system validation deliverables, from authoring and executing to reviewing and reporting, in line with regulations and company policy.

Key responsibilities

• Develop, execute and review system qualification deliverables such as requirements, plans, assessments (vendor, compliance, risk), specifications, development testing, protocols (IQ/OQ/PQ), reports, test data analysis, test issues and verification of protocol execution.
• Help develop and review SOPs for user operation, system administration and maintenance, backup and recovery, audit trail review and other SDLC process controls.
• Contribute to QMS processes such as change control projects, deviations, CAPAs and quality events, and to periodic system reviews.
• Support audits by gathering and preparing evidence.

Required profile

• Bachelor's degree in Engineering, Science, Information Technology or a related field.
• At least 1 year of experience in computer system validation.
• At least 1 year of experience in IT infrastructure and systems.
• At least 1 year of experience in a pharmaceutical, biopharmaceutical, medical device or healthcare industry.
• Valid work authorization to work full-time in the applicable location; no visa sponsorship offered.

Required skills

• Regulatory standards: 21 CFR Part 11, Annex 11, ICH (E6, E9, Q9), ISO 27001/27002.
• Industry guidance: FDA CSA, DI and general principles of software validation, GAMP (DI, GCP CSV, IT infrastructure, risk-based CSV).
• IT architecture and SaaS stack (IaaS, PaaS, SaaS, OSI model, ANSI/ISA-95).
• Business applications such as Adobe, DocuSign, eQMS, Microsoft Office, Outlook, PowerPoint, Access/SQL, Microsoft Project and Visio.