CSV Engineer I

PM Group • Indianapolis, IN

6h

About The Position

The CSV Engineer I will join PM Group’s growing Outsourced Technical Services team near Indianapolis, Indiana, supporting 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.

The work focuses on regulated laboratory systems and related interfaces, including systems used for quality control, analytical testing, sample management, and laboratory data handling. Validation activities must follow site procedures and data integrity expectations, as well as 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 serves organizations in the pharma, food, biotech, medical technology, and mission-critical sectors. The company describes itself as focused on building a sustainable business centered on its people, clients, and trade partners.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, Information Systems, or a related technical discipline.
• 1–3 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.
• 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 laboratory systems such as LIMS, CDS, ELN, SDMS, standalone instruments, instrument workstations, and related data acquisition or reporting applications.
• Document test results 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.
• 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 preparing and reviewing 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level