CQV Engineer - GMP Validation for Life Sciences Equipment

Socket.dev; Indianapolis (IN); On-site; USD 70,000 - 103,000; Full time

Job summary

Verista is seeking a Service CQV Engineer to deliver commissioning, qualification, and verification for large capital projects in the life sciences sector. You will author and execute critical CAR/URs, risk assessments, and turnover documentation for validated systems.

Role requires a bachelor’s in engineering/science and 1–3 years GMP experience, with hands-on skills in PLCs, HMIs, and PC-based controls. US-based role with comprehensive benefits and growth opportunities.

Qualifications

• Bachelor’s degree in Engineering or Scientific field.
• 1–3 years’ experience in GMP environment.
• Technical understanding of automated manufacturing equipment (PLCs, HMIs, PC-based controls).
• Experience authoring/editing validation documents (FAT/IQ/OQ/PQ) and change controls.
• Knowledge of FDA regulations, ISPE guidelines, ISO GDP in pharma environments.
• ASTM-E2500 knowledge.

Responsibilities

• Provide CQV expertise on large capital projects, ensuring CQV deliverables (URS, risk assessments, design qualifications, IQ/OQ/PQ, FAT/SAT).
• Author/execute commissioning and qualification documentation per GMP and regulatory standards.
• Review system drawings, P&ID/ I&C drawings, and electrical schematics with engineering support.

Skills

GMP experience

FDA regulations

Good Documentation Practice

Automated equipment experience

Validation documentation (FAT/IQ/OQ/PQ

Education

Bachelor’s degree in Engineering or Science

Tools

P&ID review

I&C drawings interpretation

Electrical schematics review

Job description

Verista is seeking a Service CQV Engineer to deliver commissioning, qualification, and verification for large capital projects in the life sciences sector. You will author and execute critical CAR/URs, risk assessments, and turnover documentation for validated systems.

Role requires a bachelor’s in engineering/science and 1–3 years GMP experience, with hands-on skills in PLCs, HMIs, and PC-based controls. US-based role with comprehensive benefits and growth opportunities.