Senior CSV Engineer

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.

What You Will Do Validation Strategy and Execution

• 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.

Automation and Technical Depth

• 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.

Leadership and Client Partnership

• 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.

Requirements You Will Need, Position type: Full-time, exempt. This role reports to the Account Director and is assigned to one or more project teams.

• 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 strategies and lifecycle documentation for automation and computerized systems.
• Experience with commissioning and qualification of automation platforms and manufacturing systems.
• Experience collaborating across Quality, Engineering, Manufacturing, IT, Operations, and external suppliers.

Technical Knowledge

• Working knowledge of risk-based cGMP principles, FDA regulations, EU Annex 11, Data Integrity guidance, and GAMP 5.
• Strong understanding of the computerized system validation lifecycle from concept through retirement.
• Control systems experience - Emerson DeltaV DCS, Rockwell Automation/Allen-Bradley PLCs, Siemens PLCs, FactoryTalk/RSView, or comparable platforms.
• Ability to perform and facilitate Data Integrity assessments for computerized systems.

How You Work

• Excellent written and verbal communication, with the ability to translate complex technical concepts for both engineering and business audiences.
• Self-motivated, professional, and enthusiastic, with proven leadership and mentoring skills.
• Diplomacy, respect, and a service mindset in every client interaction.

Nice to Have

• Experience supporting pharmaceutical API, Drug Substance, Drug Product, or biotechnology manufacturing facilities.
• Experience on large capital expansion projects and greenfield manufacturing facilities.
• Experience developing enterprise CSV standards, templates, and best practices.
• Experience with MES, historians, SCADA systems, and enterprise automation architectures.
• Familiarity with automated warehouses and material handling systems.
• Multi-level industrial network infrastructure design and cybersecurity considerations.
• Knowledge of virtualization, high availability, and clustered automation environments.
• Programming experience in VBA, .NET, SQL, scripting languages, or other automation-related tools.
• Experience supporting global project teams and multi-site implementations.
• Advanced degrees or professional certifications. Published research, technical presentations, or recognized industry participation are a plus.

Pulled from the full job description

• Health insurance
• 401(k) matching
• Vision insurance
• Dental insurance
• Life insurance
• Disability insurance
• Cell phone reimbursement, * Competitive base salary and biannual profit share
• Employee stock ownership program (ESOP) and 401(k) company match
• Medical, vision, and dental coverage
• Disability and life insurance
• Paid vacation and holidays
• Internal and external training opportunities
• Cellphone stipend
• Company-sponsored team building outings

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., Qualified candidates must be legally authorized to be employed in the United States. Performance Validation, Inc. does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position.