Overview We are looking for a
CSV Computer System Validation Engineer II who will support protocol execution for laboratory computer systems within a GxP manufacturing site. This individual should have a foundational understanding of computer system validation principles and a strong desire to develop hands-on experience executing validation protocols for systems used in quality control, analytical testing, sample management, and laboratory data handling. The CSV Engineer will work under the guidance of senior CSV team members to execute and document validation activities, support deviation resolution, verify system functionality against approved requirements, and ensure testing evidence is complete, accurate, and inspection-ready. Project work will focus on regulated laboratory systems and related interfaces, including protocol execution, test script completion, discrepancy documentation, and adherence to site procedures, data integrity expectations, 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable GMP requirements.
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.
- 3-5 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.
RECRUITMENT AGENCIES NEED NOT APPLY#LI-MG1 
