CQV Engineer: GMP Validation & Commissioning Expert

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

Benefits offered by this job

Medical, Dental & Vision insurances

401(k) Retirement Plan (Employer Match

Tuition Reimbursement

Paid Time Off and Holidays

Life Insurance

Job summary

Verista is seeking a Service CQV Engineer to support large capital projects by delivering commissioning, qualification, and verification activities for automated manufacturing equipment and facilities.

The role requires a Bachelor’s in Engineering or Science and 1–3 years in GMP environments, with experience in FAT/IQ/OQ/PQ, risk assessment, and change control. You will collaborate with clients’ quality teams to ensure compliance and successful project turnover.

Qualifications

• Minimum 1–3 years’ experience in GMP environment.
• Experience with automated manufacturing equipment, device assembly, and packaging.
• Experience authoring/editting/execiting validation documents (FAT/IQ/OQ/PQ, change controls).
• Knowledge of FDA regulations, ISPE guidelines, ISO standards including GDP.

Responsibilities

• Provide CQV expertise on large capital projects delivering CQV across URS, risk assessment, design qualification, start-up, and turnover documents.
• Author and execute commissioning/QA documents for complex automated equipment/processes per quality standards and GMP.
• Review drawings, P&ID, I&C drawings, and electrical schematics with engineering support.
• Collaborate with clients’ quality reps to resolve deviations and maintain records for audits.
• Adapt project deliverables to customer requirements and scope.

Skills

GMP experience

Automated equipment

PLCs HMIs PC controls

Qualification documentation

FDA ISPE GDP knowledge

Education

Bachelor’s degree in Engineering or Science

Job description

Verista is seeking a Service CQV Engineer to support large capital projects by delivering commissioning, qualification, and verification activities for automated manufacturing equipment and facilities.

The role requires a Bachelor’s in Engineering or Science and 1–3 years in GMP environments, with experience in FAT/IQ/OQ/PQ, risk assessment, and change control. You will collaborate with clients’ quality teams to ensure compliance and successful project turnover.