Senior CSV Engineer

Performance Validation; Indianapolis (IN); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

ESOP

401(k) match

Medical coverage

Dental coverage

Paid vacation

Job summary

Performance Validation in Indianapolis seeks a Senior CSV Engineer. This OT-side validation focuses on process automation, control systems, and manufacturing equipment, not ERP.

You will define validation strategy and lead lifecycle documentation, while collaborating with quality, engineering, IT, and manufacturing teams to ensure regulatory compliance. You will mentor colleagues, drive standardized validation templates, and support audits, with a strong emphasis on data integrity and risk-based

Qualifications

• Five+ years in pharmaceutical/regulated manufacturing environments with automation engineering, C&Q, CSV.
• Experience validating GMP manufacturing systems with protocol execution and final reports.
• Experience developing lifecycle docs for automation and computerized systems.
• Experience commissioning and qualification of automation platforms and manufacturing systems.
• Ability to collaborate across Quality, Engineering, Manufacturing, IT, Operations, and suppliers.

Responsibilities

• Develop qualification and testing strategies for process automation across full lifecycle using risk-based scope.
• Lead planning, development, execution, and review of CSV documentation (URs, FS, VPs, IQ/OQ/PQ, reports).
• Execute validation activities in GMP environments including field testing and turnover to operations.
• Perform Data Integrity assessments and support remediation per regulatory expectations.

Skills

Technical leadership

Mentoring

Communication

Regulatory compliance

Education

Four-year engineering degree

Tools

Emerson DeltaV DCS

Rockwell/Allen-Bradley PLCs

Siemens PLCs

FactoryTalk/RSView

Job description

Please see the links below for our current opportunities:

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 Id:420

# of Openings:1

About Us

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.

About the Job

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
Education

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

Experience

• 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.

What We Have to Offer

• 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

Additional Information

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

Travel: Occasional travel is required in support of project and client needs.

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.

Performance Validation is an Equal Opportunity Employer

We believe in the dignity, value, and potential of every individual. Performance Validation provides equal employment opportunities to all employees and applicants and makes employment decisions based on qualifications, merit, and business needs.

We do not discriminate on the basis of race, color, religion, creed, national origin, citizenship status, age, sex, pregnancy, sexual orientation, gender identity, marital status, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law. Performance Validation is committed to maintaining a workplace free from discrimination, harassment, and retaliation. We prohibit conduct that demeans, intimidates, threatens, or creates an offensive work environment based on any protected characteristic. Reasonable accommodations are available for qualified individuals with disabilities throughout the application and employment process.