Senior CSV Engineer

PM Group•Indianapolis, IN

5d•Onsite

About The Position

The Senior CSV Engineer is a senior-level Computer System Validation role with PM Group’s Outsourced Technical Services team, supporting a GxP manufacturing site near Indianapolis, Indiana. The position focuses on hands-on execution of validation protocols for laboratory computerized systems used in quality control, analytical testing, sample management, laboratory data acquisition, instrument control, electronic records, and related laboratory operations. The engineer executes IQ, OQ, and PQ protocols and test scripts, documents objective evidence, manages protocol exceptions and deviations, and helps ensure systems are fit for intended use and compliant with cGMP, data integrity, 21 CFR Part 11, EU Annex 11, and GAMP 5 expectations. The role works independently in a site-based environment and coordinates with QC laboratories, Quality Assurance, IT/OT, automation, vendors, manufacturing stakeholders, and other partners. Senior-level technical judgment is expected for protocol execution, issue resolution, and release-readiness activities. 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 the pharma, food, biotech, medical technology, and mission-critical sectors, and focuses on growing a sustainable business centered on its people, clients, and trade partners.

Requirements

Bachelor’s degree in engineering, life sciences, computer science, information systems, chemistry, biology, laboratory science, automation, or a related technical discipline.
5–10 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, and 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 as applied to laboratory systems.
Ability to clearly document test execution, collect objective evidence, resolve protocol exceptions, support deviation investigations, and prepare executed protocols for quality review.
Ability to work independently in a site-based GxP manufacturing environment and coordinate testing with QC laboratories, Quality Assurance, IT/OT, automation, metrology, vendors, and manufacturing operations.
Strong attention to detail and ability to identify documentation gaps, data integrity concerns, testing inconsistencies, configuration issues, and execution risks.
Strong technical writing, communication, facilitation, issue resolution, and stakeholder management skills.
Ability to work on-site as needed for laboratory protocol execution, testing coordination, issue resolution, and documentation closeout.

Nice To Haves

Knowledge of laboratory workflows, analytical testing processes, sample management, instrument control, audit trails, electronic records, electronic signatures, reporting, calculations, and data review practices.
Experience supporting change control, system upgrades, security or access control changes, instrument additions, patching, periodic reviews, and maintenance of the validated state.
Experience mentoring junior CSV resources or providing technical execution guidance.

Responsibilities

Execute CSV protocols and test scripts, including IQ, OQ, and PQ, for laboratory computerized systems at a GxP manufacturing site.
Support validation of LIMS, chromatography data systems, laboratory instrument software, balances, analyzers, environmental monitoring interfaces, data acquisition systems, and other QC laboratory applications.
Perform testing in accordance with approved protocols, site procedures, good documentation practices, and applicable data integrity expectations.
Collect, verify, and attach objective evidence, including screenshots, audit trail records, configuration records, instrument outputs, user access evidence, electronic signature evidence, and test results.
Document protocol discrepancies, test exceptions, deviations, and unexpected results; support investigations, impact assessments, corrective actions, and retesting as needed.
Review executed protocols and test evidence for completeness, accuracy, traceability, and inspection readiness before quality review or approval.
Assess system functionality against approved requirements and intended use, including user roles, security settings, audit trails, electronic records and signatures, calculations, reports, interfaces, and data flows.
Coordinate protocol execution 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 documentation closeout.
Apply risk-based CSV principles, cGMP, GAMP 5, 21 CFR Part 11, EU Annex 11, and site procedures to help ensure laboratory systems remain compliant and fit for intended use.
Support change controls, configuration changes, system upgrades, instrument additions, user access changes, patching, and other lifecycle events affecting validated systems.
Provide senior technical guidance during protocol execution, coach junior validation resources, resolve testing questions, and escalate risks or blockers.
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, inspection-defensible CSV documentation to support audit readiness and the continued validated state of laboratory systems.