GMP-Driven Commissioning & Qualification Engineer

Capgemini; Hopkinsville (KY); On-site; USD 54,000 - 118,000; Full time

Benefits offered by this job

Paid time off

Medical, dental, and vision coverage

401(k) retirement plan

Life and disability insurance

Job summary

Capgemini in Hopkinsville, KY is seeking an detail-oriented Associate Commissioning & Qualification Engineer to manage IQ/OQ/PQ activities within a regulated environment. The role focuses on coordinating installation qualification, calibration, and qualification activities to ensure equipment and processes meet GMP, FDA, and ISO standards.

You will develop, review, and execute IQ/OQ/PQ protocols, verify results, document deviations, and prepare final qualification reports.

Qualifications

• Bachelor’s degree in engineering, Life Sciences, or a related field.
• 3–5 years of experience in equipment qualification or validation in a regulated industry (e.g., Pharma/Life Sciences/MedTech).
• Strong knowledge of IQ/OQ/PQ processes and regulatory standards.
• Excellent analytical and problem-solving skills.

Responsibilities

• Install IQ, OQ, and PQ activities for equipment and systems.
• Review results, prepare summaries, and ensure regulatory compliance.
• Identify and address deviations; re-test as needed; maintain compliant documentation.
• Support audits, CAPA, and cross-functional qualification projects.

Skills

IQ/OQ/PQ

Regulatory knowledge

Analytical skills

Education

Bachelor’s degree (engineering / life sciences / related)

Job description

Capgemini in Hopkinsville, KY is seeking an detail-oriented Associate Commissioning & Qualification Engineer to manage IQ/OQ/PQ activities within a regulated environment. The role focuses on coordinating installation qualification, calibration, and qualification activities to ensure equipment and processes meet GMP, FDA, and ISO standards.

You will develop, review, and execute IQ/OQ/PQ protocols, verify results, document deviations, and prepare final qualification reports.