Computer System Validation Engineer

About the role

ProPharma is seeking a Computer System Validation Engineer to author, execute, review, and report on validation deliverables in line with regulatory requirements and company policies. The role supports the full lifecycle of computer systems used in biotech, medical device, and pharmaceutical environments.

Key responsibilities

• Develop, execute, and review system qualification deliverables, including requirements, plans, risk assessments, specifications, testing, IQ/OQ/PQ protocols and reports.
• Assist in creating and reviewing SOPs for system operation, administration, backup/recovery, and audit‑trail review.
• Participate in QMS processes such as Change Control, Deviations, CAPAs, and Quality Events.
• Support periodic system reviews and audit evidence preparation.

Required profile

• B.S./B.A. in Engineering, Science, IT or related field.
• Minimum 1 year experience in Computer System Validation, IT infrastructure, and pharmaceutical/medical‑device environments.
• Valid work authorization for the location; no visa sponsorship offered.

Required skills

• Knowledge of regulatory standards: 21 CFR Part 11, Annex 11, ICH E6/E9/Q9, ISO 27001/27002.
• Familiarity with FDA guidance (CSA, DI), GAMP (DI, GCP CSV, risk‑based CSV).
• Understanding of IT/network architecture layers, OSI model, ANSI/ISA‑95.
• Experience with SaaS stack concepts (IaaS, PaaS, SaaS) and shared‑responsibility models.
• Proficiency with business applications: Adobe, DocuSign, eQMS, Microsoft Office suite (Word, Excel, Outlook, PowerPoint, Access/SQL, Project, Visio).