CSV Engineer II

PM Group•Indianapolis, IN

About The Position

PM Group is seeking a CSV Computer System Validation Engineer II to join its Outsourced Technical Services team near Indianapolis, Indiana. The role supports protocol execution for laboratory computer systems at a GxP manufacturing site. Working under the guidance of senior CSV team members, the engineer will execute and document validation activities, support deviation resolution, verify system functionality against approved requirements, and ensure testing evidence is complete, accurate, and inspection-ready. Work focuses on regulated laboratory systems and related interfaces, with adherence to site procedures, data integrity expectations, 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable GMP requirements. PM Group is an employee-owned international project delivery firm with more than 4,000 people and over 50 years of industry experience. It works across the pharma, food, biotech, medical technology, and mission-critical sectors, supporting clients throughout the project life cycle.

Requirements

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.
Strong attention to detail and technical writing ability, with a commitment to clear, complete, and inspection-defensible documentation.
Ability to collaborate 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.

Nice To Haves

Familiarity with 21 CFR Part 11, EU Annex 11, GAMP 5, and risk-based validation concepts.
Experience executing test scripts, documenting evidence, managing discrepancies, or supporting validation documentation.
Exposure to laboratory systems such as LIMS, CDS, ELN, SDMS, analytical instruments, or instrument control software.

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 LIMS, CDS, ELN, SDMS, standalone instruments, instrument workstations, and related data acquisition or reporting applications.
Document test results, objective evidence, and traceability to approved requirements, including screenshots, printouts, and attachments.
Identify, document, and escalate protocol discrepancies, test failures, and deviations according to site quality procedures.
Verify user access, audit trails, electronic records, electronic signatures, data integrity controls, backup and 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.