CSV Engineer I

Responsibilities

• Execute approved CSV protocols and test scripts for laboratory computer systems in accordance with site procedures, project schedules, and GxP requirements.
• Support validation activities for laboratory systems such as LIMS, CDS, ELN, SDMS, standalone instruments, instrument workstations, and related data acquisition or reporting applications.
• Document test results clearly and accurately, including objective evidence, screenshots, printouts, attachments, and traceability to approved requirements.
• Identify, document, and escalate protocol discrepancies, test failures, and deviations in accordance with site quality procedures.
• Perform verification of user access, audit trails, electronic records, electronic signatures, data integrity controls, backup/restore, and other applicable Part 11 and Annex 11 requirements.
• Assist with preparation and review of validation deliverables, including test protocols, requirements traceability matrices, summary reports, and supporting attachments.
• Coordinate with laboratory operations, Quality, IT, Automation, vendors, and senior CSV resources to schedule and complete testing without disrupting manufacturing or laboratory operations.
• Maintain compliance with PM Group’s Service Delivery Platforms, Quality Management System, client procedures, and applicable GMP expectations.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, Information Systems, or a related technical discipline.
• 0-3 years of experience in computer system validation, laboratory systems, quality control, IT, automation, or pharmaceutical manufacturing support.
• Foundational knowledge of GxP, GMP documentation practices, data integrity, and computer system validation lifecycle principles.
• Familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5, and risk-based validation concepts is preferred.
• Experience executing test scripts, documenting evidence, managing discrepancies, or supporting validation documentation is preferred.
• Exposure to laboratory systems such as LIMS, CDS, ELN, SDMS, analytical instruments, or instrument control software is a plus.
• Strong attention to detail, technical writing ability, and commitment to producing clear, complete, and inspection-defensible documentation.
• Ability to work collaboratively with laboratory personnel, Quality, IT, vendors, and project team members in a regulated manufacturing environment.
• Proficiency with Microsoft Word, Excel, and standard documentation tools.
• Ability to travel as needed for client and project support.