Commissioning & Qualification Engineer

Location

This is an onsite role in Hopkinsville, KY

About the job you're considering

We are seeking a detail-oriented and compliance-driven Associate Commissioning & Qualification Engineer to manage and execute equipment and system qualification activities within a regulated environment. The successful candidate will be responsible for coordinating Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities to ensure equipment, systems, and processes meet regulatory, quality, and operational requirements.

This role requires hands-on experience with qualification protocols, deviation management, validation documentation, and compliance with industry standards such as GMP, GxP, FDA, ISO, and MedTech regulations.

Your Role

• Installation Qualification IQ
• Develop, review, and execute IQ protocols to verify proper installation of equipment and systems.
• Ensure accurate documentation, protocol approvals, and compliance with regulatory requirements.
• Review qualification results and prepare IQ summary reports.
• Operational Qualification OQ
• Develop, review, approve, and execute OQ protocols and test plans.
• Verify equipment functionality, calibration, and operational performance.
• Identify, document, investigate, and resolve deviations; re-execute failed tests as needed.
• Ensure training completion and maintain compliant OQ documentation.
• Prepare OQ reports and qualification summaries.
• Performance Qualification PQ
• Develop, review, approve, and execute PQ protocols.
• Perform process verification to confirm consistent performance under routine operating conditions.
• Ensure PQ training completion, resolve deviations, and document qualification outcomes.
• Prepare final PQ reports and qualification documentation.
• Compliance & Documentation
• Maintain qualification protocols, reports, and validation records.
• Ensure compliance with GMP, GxP, FDA, ISO, and other applicable standards.
• Support audits, change controls, CAPA activities, and cross-functional qualification projects.

Your skills and experience

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

The base compensation range for this role in the posted location is: $54,380 - $118,144/year

Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay transparency laws. The base compensation range listed for this position reflects the minimum and maximum target compensation Capgemini, in good faith, believes it may pay for the role at the time of this posting. This range may be subject to change as permitted by law.

The actual compensation offered to any candidate may fall outside of the posted range and will be determined based on multiple factors legally permitted in the applicable jurisdiction.

These may include, but are not limited to: Geographic location, Education and qualifications, Certifications and licenses, Relevant experience and skills, Seniority and performance, Market and business consideration, Internal pay equity.

It is not typical for candidates to be hired at or near the top of the posted compensation range.

In addition to base salary, this role may be eligible for additional compensation such as variable incentives, bonuses, or commissions, depending on the position and applicable laws.

Capgemini offers a comprehensive, non-negotiable benefits package to all regular, full-time employees. In the U.S. and Canada, available benefits are determined by local policy and eligibility and may include:

• Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave

• Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life and disability insurance
• Employee assistance programs
• Other benefits as provided by local policy and eligibility

Important Notice: Compensation (including bonuses, commissions, or other forms of incentive pay) is not considered earned, vested, or payable until it becomes due under the terms of applicable plans or agreements and is subject to Capgemini's discretion, consistent with applicable laws. The Company reserves the right to amend or withdraw compensation programs at any time, within the limits of applicable legislation.