Qualification Engineer

Capgemini • Bridgewater, NJ

23h

About The Position

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

About the job you’re considering
The Qualification Program (IQ/OQ/PQ) Administrator is responsible for overseeing the Installation, Operational, and Performance Qualification of equipment and systems in a regulated environment. This role ensures that all qualification activities are planned, executed, documented, and approved in compliance with applicable regulatory requirements, quality standards, and organizational objectives. The administrator plays a key role in ensuring equipment reliability, product quality, and patient safety.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related discipline.
• 3–5 years of experience in equipment qualification and/or validation within a regulated industry.
• Strong working knowledge of IQ/OQ/PQ methodologies and validation lifecycle practices.
• Solid understanding of cGMP, FDA, and other applicable regulatory requirements.
• Excellent analytical, troubleshooting, and problem-solving skills.
• Strong written and verbal communication skills with the ability to collaborate across cross-functional teams.
• Proficiency in data analysis, documentation, and reporting tools.
• Demonstrated ability to manage multiple priorities while maintaining quality and compliance standards

Responsibilities

• Define and establish clear Installation Qualification (IQ) requirements, ensuring accuracy, completeness, and alignment with regulatory and organizational standards.
• Prepare, review, and obtain approval of IQ protocols prior to execution.
• Execute IQ activities in accordance with approved protocols and regulatory expectations.
• Ensure thorough documentation, review, and completion of all IQ activities, including post-execution assessments and summary reports.
• Initiate, develop, and review Operational Qualification (OQ) requirements to ensure alignment with project goals and compliance standards.
• Prepare, review, and obtain approval of OQ plans and protocols prior to execution.
• Execute OQ testing and ensure proper calibration, functionality, and performance of equipment.
• Ensure completion and verification of OQ training for involved personnel.
• Identify, document, investigate, and resolve deviations encountered during OQ execution.
• Re-execute failed OQ tests as required to achieve compliance.
• Review and approve OQ protocols and ensure all documentation meets quality and regulatory expectations.
• Prepare comprehensive Quality Summary Reports covering IQ and OQ activities, deviations, and compliance status.
• Initiate, review, and approve Performance Qualification (PQ) requirements and plans.
• Execute PQ protocols and perform process verification to confirm consistent and reproducible performance.
• Ensure completion, documentation, and verification of all PQ activities in alignment with regulatory and quality standards.

Benefits

• Medical, dental, and vision coverage
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life and disability insurance
• Employee assistance programs
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level