CQV Engineer - GMP Validation for Life Sciences

Verista; Indianapolis (IN); On-site; USD 70,000 - 103,000; Full time

Benefits offered by this job

Competitive pay

401(k) matching

Paid time off

Tuition reimbursement

Health benefits

Job summary

Verista, a leading life sciences solutions provider, seeks a CQV Engineer to deliver commissioning, qualification, and validation on large capital projects. You will author and execute complex documentation, review system drawings, and work with clients’ quality teams to resolve deviations.

A solid GMP background and familiarity with regulatory standards are essential. Successful candidates will have a Bachelor's degree in engineering or science and 1–3 years’ GMP experience.

Qualifications

• Bachelor's degree in Engineering or Scientific field required.
• 1-3 years' experience in GMP regulated environment.
• Technical understanding of automated manufacturing equipment (PLC/HMI/PC controls).
• Experience authoring/editing/exec. validation docs (FAT/IQ/OQ/PQ) and change controls.
• Knowledge of FDA regulations, ISPE guidelines, ISO standards including GDP in pharma.

Responsibilities

• Provide CQV expertise on large capital projects ensuring CQV deliverables (URS, validation docs, IQ/OQ/PQ, FAT/SAT).
• Author and execute commissioning/qualification documentation per quality standards and GMP requirements.
• Review drawings (P&IDs, I&C, electrical schematics) with engineering support.
• Coordinate with clients' quality reps to resolve deviations and maintain records for audits.
• Adapt project assignments to customer-defined deliverables.

Skills

GMP environment

Automated equipment

Validation docs (FAT IQ PQ)

FDA regulations & ISPE GDP

ASTM-E2500

Education

Bachelor's degree in Engineering or Scientific degree

Job description

Verista, a leading life sciences solutions provider, seeks a CQV Engineer to deliver commissioning, qualification, and validation on large capital projects. You will author and execute complex documentation, review system drawings, and work with clients’ quality teams to resolve deviations.

A solid GMP background and familiarity with regulatory standards are essential. Successful candidates will have a Bachelor's degree in engineering or science and 1–3 years’ GMP experience.