Overview

The CSV Engineer III position is an exciting opportunity to join PM Group's quickly growing Outsourced Technical Services(OTS) team at a site near Indianapolis, IN. Outsourced Technical Services (OTS) is an integral part of PM Group's ability to support clients across the complete project life cycle. We have over 50 years' industry experience, strong technical knowledge and integrated resources. Clients look to us to provide experienced technical professionals that complement their project teams. Together we are sharing knowledge, learning, growing and continuing to be an integral part of supporting PM Group's ongoing expansion in the US.

This is a senior-level Computer System Validation (CSV) role for an experienced validation professional who will focus on executing CSV protocols for laboratory computerized systems in a GxP manufacturing site. The CSV Engineer III will support validation activities for systems used in quality control, analytical testing, sample management, laboratory data acquisition, instrument control, electronic records, and related lab operations. The role requires strong hands-on experience executing IQ, OQ, PQ, and test scripts; documenting objective evidence; managing protocol exceptions and deviations; and ensuring laboratory systems are fit for intended use and compliant with cGMP, data integrity, 21 CFR Part 11, EU Annex 11, and GAMP 5 expectations. This individual is expected to work independently in a site-based environment, coordinate closely with QC laboratories, Quality Assurance, IT/OT, automation, vendors, and manufacturing stakeholders, and provide senior-level technical judgment during protocol execution, issue resolution, and release-readiness activities.

Responsibilities

• Execute CSV protocols and test scripts for laboratory computerized systems in a GxP manufacturing site, including IQ, OQ, PQ.
• Support validation of laboratory systems such as LIMS, chromatography data systems, laboratory instrument software, balances, analyzers, environmental monitoring interfaces, data acquisition systems, and other QC laboratory applications.
• Perform test execution in accordance with approved protocols, site procedures, good documentation practices, and applicable data integrity expectations.
• Collect, verify, and attach complete objective evidence, including screenshots, audit trail records, configuration records, instrument outputs, user access evidence, electronic signature evidence, and test result documentation.
• Document protocol discrepancies, test exceptions, deviations, and unexpected results clearly and accurately, and support investigation, impact assessment, corrective actions, and retesting as required.
• Review executed protocols and test evidence for completeness, accuracy, traceability, and inspection readiness prior to quality review or approval.
• Assess laboratory system functionality against approved requirements, intended use, user roles, security settings, audit trails, electronic records, electronic signatures, calculations, reports, interfaces, and data flows.
• Coordinate protocol execution activities with QC laboratory personnel, manufacturing operations, Quality Assurance, IT/OT, automation, metrology, vendors, and system owners to minimize operational disruption.
• Support validation planning, test readiness checks, pre-execution reviews, scheduling, system access preparation, test data preparation, and post-execution documentation closeout.
• Apply risk-based CSV principles, cGMP, GAMP 5, 21 CFR Part 11, EU Annex 11, and site procedures to ensure laboratory computerized systems remain compliant and fit for intended use.
• Support change controls, configuration changes, system upgrades, instrument additions, user access changes, patching activities, and other lifecycle events affecting validated laboratory systems.
• Provide senior-level technical guidance during protocol execution, including coaching junior validation resources, resolving testing questions, and escalating risks or blockers appropriately.
• Communicate execution status, open issues, deviation status, documentation gaps, and readiness risks to project leadership, site quality, system owners, and client stakeholders.
• Maintain complete, accurate, and inspection-defensible CSV documentation to support audit readiness and continued validated state of laboratory systems.

Qualifications

• Bachelor's degree in engineering, life sciences, computer science, information systems, chemistry, biology, laboratory science, automation, or a related technical discipline is required.
• 8+ years of experience in computer system validation, laboratory system validation, quality systems, automation validation, or related GxP validation roles in pharmaceutical, biotechnology, or life sciences manufacturing environments.
• Demonstrated senior-level experience executing CSV protocols for laboratory computerized systems in a regulated manufacturing or quality control laboratory environment.
• Hands-on experience executing IQ, OQ, PQ, test scripts.
• Experience with laboratory systems such as LIMS, chromatography data systems, laboratory instrument software, analytical instruments, electronic notebooks, data acquisition systems, environmental monitoring interfaces, or similar QC laboratory applications.
• Strong understanding of cGMP, GAMP 5, risk-based validation, good documentation practices, data integrity, 21 CFR Part 11, and EU Annex 11 requirements as applied to laboratory systems.
• Proven ability to document test execution clearly, collect objective evidence, resolve protocol exceptions, support deviation investigations, and prepare executed protocols for quality review.
• Knowledge of laboratory workflows, analytical testing processes, sample management, instrument control, audit trails, electronic records, electronic signatures, reporting, calculations, and data review practices is strongly preferred.
• Ability to work independently in a site-based GxP manufacturing environment and coordinate testing activities with QC laboratories, Quality Assurance, IT/OT, automation, metrology, vendors, and manufacturing operations.
• Strong attention to detail with the ability to identify documentation gaps, data integrity concerns, testing inconsistencies, configuration issues, and execution risks.
• Experience supporting change control, system upgrades, security or access control changes, instrument additions, patching, periodic reviews, and maintaining the validated state is preferred.
• Strong technical writing, communication, facilitation, issue resolution, and stakeholder management skills are required.
• Experience mentoring junior CSV resources or providing technical execution guidance is preferred.
• Ability to work on-site as needed to support laboratory protocol execution, testing coordination, issue resolution, and documentation closeout.

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