Senior CSV Engineer: Automation Validation Leader

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

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