Pharma CSV Validation Engineer (Hybrid)

Simotechnology; Indianapolis (IN); Hybrid; USD 90,000 - 130,000; Full time

Job summary

SimoTech in Indianapolis, Indiana, seeks an Automation CSV Engineer to join our expanding US projects team in the pharma/biotech space. You will validate computerised systems within the process automation framework, ensuring compliance with 21 CFR Part 11, EU Annex 11, and GAMP5, while working across DeltaV and Siemens PLC platforms.

The successful candidate will develop validation strategies, prepare documents (URS, FRS, IQ/OQ/PQ), perform PV/PQ tests, manage change controls, and support audits

Qualifications

• Bachelor's degree or higher in Engineering/IS/CS/Life Sciences.
• 5+ years' CSV Engineer experience in pharma/biotech.
• Solid knowledge of 21 CFR Part 11, EU Annex 11, GAMP5 and data integrity.
• Hands-on validation experience with DeltaV and Siemens PLC systems.

Responsibilities

• Develop and execute validation strategies for new and existing systems.
• Support validation of DeltaV, Siemens PLC, PI and other automation platforms.
• Prepare and review URS, FRS, IQ/OQ/PQ, and validation plans.
• Create traceability matrices linking requirements, design and testing.
• Perform risk and impact assessments and manage change controls.

Skills

Communication skills

Stakeholder management

Independent work

Team collaboration

Education

Bachelor's degree in Engineering/IS/CS/Life Sciences

Tools

DeltaV

Siemens PLC

Job description

SimoTech in Indianapolis, Indiana, seeks an Automation CSV Engineer to join our expanding US projects team in the pharma/biotech space. You will validate computerised systems within the process automation framework, ensuring compliance with 21 CFR Part 11, EU Annex 11, and GAMP5, while working across DeltaV and Siemens PLC platforms.

The successful candidate will develop validation strategies, prepare documents (URS, FRS, IQ/OQ/PQ), perform PV/PQ tests, manage change controls, and support audits