CQV Engineer – GMP Equipment Validation

Verista; Indianapolis, Northern (IN, KY); Hybrid; USD 70,000 - 103,000; Full time

Benefits offered by this job

Competitive pay

Life Insurance

Disability Insurance

Tuition Reimbursement

Paid Time Off

Job summary

Verista’s Indianapolis team seeks a qualified professional to support commissioning, qualification, and validation activities for life-science manufacturing projects. You will author and execute validation documentation and verify system drawings, ensuring compliance with GMP and industry standards.

The role requires hands-on experience with automated equipment, FAT/IQ/OQ/PQ processes, and collaboration with clients’ quality representatives.

Qualifications

• Bachelor’s degree in engineering or a scientific field.
• 1–3 years’ experience in GMP-regulated environment.
• Experience with automated manufacturing equipment and packaging.
• Direct experience authoring and executing validation documents (FAT/IQ/OQ/PQ) and change controls.
• Knowledge of FDA regulations, ISPE guidelines, ISO GDP in pharma.
• ASTM-E2500

Responsibilities

• Provide CQV expertise on large capital projects with new or modified equipment and utilities.
• Author and execute commissioning/qualification documentation per client quality standards.
• Review drawings including as-built P&IDs and I&C diagrams with engineering support.
• Coordinate deviation investigations and maintain records for audits.
• Vary project assignments based on customer needs and defined deliverables.

Skills

Automated equipment experience

P&ID review

FDA/ISPE/ISO knowledge

Validation documentation

Education

Bachelor's degree in engineering or scientific field

Tools

PLCs

HMIs

PC-based controls

Job description

Verista’s Indianapolis team seeks a qualified professional to support commissioning, qualification, and validation activities for life-science manufacturing projects. You will author and execute validation documentation and verify system drawings, ensuring compliance with GMP and industry standards.

The role requires hands-on experience with automated equipment, FAT/IQ/OQ/PQ processes, and collaboration with clients’ quality representatives.