Senior CSV Engineer

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Certain positions at Performance Validation are designated as safety sensitive based on job duties and applicable law. Applicants for these roles may be subject to pre-employment drug testing, including for cannabinoids, where permitted by law.

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Location: Indianapolis, IN

Job :420

# of Openings:1

Here at Performance Validation, Inc. (PV) we have been providing Commissioning, Qualification, and Validation services to the life science industries for over 30 years! We are a 100% employee-owned company with teams in Indiana, Michigan, Illinois, Kansas, Washington, Wisconsin, and North Carolina, and we support clients throughout the US and overseas. As an employer, PV is committed to providing growth opportunities to our employees through professional development, implementation of new services, and cultivation of new geographical areas.

Performance Validation is seeking a Senior CSV Engineer to join our Indianapolis team. To be clear about scope up front: this is OT-side validation - process automation, control systems, and manufacturing equipment on the plant floor, not enterprise IT systems. If your background is in DCS and PLC platforms rather than ERP and business applications, you are in the right place.

This is a senior technical role for someone who has moved past executing other people's protocols and is ready to define the strategy - deciding how a system should be qualified, not just running the test.

You will serve as our technical leader in automation lifecycle management, computer system validation, commissioning and qualification, data integrity, and regulatory compliance. Our clients bring us their hardest automation problems: greenfield facilities, complex DCS and PLC platforms, data integrity remediation, systems where the right validation approach is not obvious. You will be the person they ask, and you will work directly alongside their quality, engineering, IT, and manufacturing teams to build validation strategies that hold up to regulatory scrutiny and still let the project move.

• Develop qualification and testing strategies for process automation systems across the full system lifecycle, applying risk-based principles to determine appropriate qualification scope, testing approach, and lifecycle controls.
• Lead the planning, development, execution, and review of C&Q and CSV documentation - User Requirements, Functional and Design Specifications, Validation Plans, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, Summary Reports, and software lifecycle documentation.
• Execute validation activities in GMP environments including protocol walkdowns, field testing, discrepancy resolution, commissioning support, and turnover to operations.
• Perform Data Integrity assessments for computerized systems and support remediation in line with regulatory expectations.

• Perform source code reviews and participate in design reviews to ensure automation solutions meet quality, validation, cybersecurity, and compliance expectations.
• Contribute to electrical system design, automation software, PLC programming, and debugging as project needs require.
• Support commissioning and qualification planning for GMP manufacturing facilities and process automation systems.

• Advise clients on industry best practices, and serve as the subject matter expert for automation validation, Data Integrity, GAMP, and risk-based validation methodologies.
• Provide technical leadership during audits, inspections, client assessments, and regulatory interactions.
• Mentor and empower colleagues, and influence both technical and management teams through collaboration and sound engineering judgment.
• Build standardized validation templates, testing approaches, and reusable documentation that make every subsequent project faster and more consistent.
• Serve as a key resource in developing new services, technologies, standards, and best practices for the firm.

• A four-year degree in Electrical Engineering, Computer Engineering, Chemical Engineering, Mechanical Engineering, Computer Science, Life Sciences, or another related technical discipline.

• Five or more years supporting pharmaceutical, biotechnology, or other regulated manufacturing environments, including automation engineering, C&Q, CSV, process automation.
• Demonstrated experience executing validation testing in GMP manufacturing environments, including protocol execution, discrepancy management, and final report generation.
• Experience developing validation…