Computer System Validation Engineer

Location: Belgrade, Serbia; remote work is supported, with hybrid work encouraged for new hires within a reasonably short commute of an office

Company

hirify.global provides consulting solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Develop, execute, review, and report on computer system validation and qualification deliverables.
• Create and manage requirements, assessments, specifications, development testing, IQ/OQ/PQ protocols, reports, and test issues.
• Support SOP development for system operation, administration, maintenance, backup and recovery, and audit trail review.
• Contribute to QMS processes including change controls, deviations, CAPAs, quality events, and periodic system reviews.
• Prepare evidence and support audits.

Requirements

• 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 with IT infrastructure and systems.
• At least 1 year of experience in the pharmaceutical, biopharmaceutical, medical device, or healthcare industry.
• Working knowledge of CSV and data integrity regulations and standards, including 21 CFR Part 11, Annex 11, ICH, and ISO 27001/27002.
• Valid work authorization for full-time work in Serbia is required; visa sponsorship is not available.

Nice to have

• Knowledge of FDA, GAMP, risk-based CSV, and software validation practices.
• Understanding of network architecture, the OSI Model, ANSI/ISA-95, and IaaS/PaaS/SaaS shared responsibility models.
• Experience with Adobe, DocuSign, eQMS, Microsoft Office, Access/SQL, Microsoft Project, or Visio.

Culture & Benefits

• Remote working is supported, with in-person collaboration encouraged where practical.
• Hybrid office work may be agreed with the manager for employees located near an office.
• Inclusive workplace focused on diversity, equity, and inclusion.
• Environment supporting innovation, collaboration, entrepreneurship, and individual authenticity.

Hiring process

• Applications are personally reviewed by a member of the recruitment team.
• AI screening tools are not used.
• Applicants receive an outcome after the application review.