Senior CSV Engineer

PerfVal Labs, Inc.•Indianapolis, IN

17h•Hybrid

About The Position

Performance Validation is seeking a Senior CSV Engineer to join our Indianapolis team. This role focuses on Operational Technology (OT)-side validation, specifically process automation, control systems, and manufacturing equipment on the plant floor, rather than enterprise IT systems. This is a senior technical leadership role responsible for defining validation strategies and approaches for automation lifecycle management, computer system validation, commissioning and qualification, data integrity, and regulatory compliance. The engineer will work directly with clients' quality, engineering, IT, and manufacturing teams to develop validation strategies that meet regulatory scrutiny and project timelines, addressing complex automation challenges such as greenfield facilities, intricate DCS and PLC platforms, and data integrity remediation.

Requirements

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.
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.
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.
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.

Nice To Haves

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.

Responsibilities

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.