Manufacturing Equipment Qualification (IQ/OQ/PQ) Engineer

Capgemini • Mclean, VA

5d • Onsite

About The Position

The Qualification Program (IQ/OQ/PQ) is responsible for overseeing the installation, operational, and performance qualification of equipment and systems in compliance with regulatory standards. This role ensures that all equipment operates within specified parameters and meets quality and safety requirements.

Requirements

• Min of 3 Years of Experience
• Bachelor's degree in Science, Engineering, or a related field.
• Strong background in Computer System Validation (CSV).
• Hands-on experience executing IQ/OQ/PQ protocols.
• Proven experience developing Validation Master Plans (VMPs), validation protocols, and final reports.
• Solid understanding of equipment and process validation.
• Demonstrated ability to manage and support Change Controls, Deviations, CAPAs, and inspection readiness activities.
• Strong communication, problem-solving, and cross-functional collaboration skills.
• Candidates must be U.S. Citizens or Green Card holders.

Responsibilities

• Verify that equipment is installed according to manufacturer specifications and site requirements.
• Document the installation process, including utility connections, environmental conditions, and component verification.
• Ensure all necessary documentation, such as manuals and certificates, are available and complete.
• Develop and approve OQ protocols that outline the tests to be performed to verify equipment operation.
• Conduct tests to ensure the equipment operates according to predefined specifications under normal operating conditions.
• Document test results, any deviations, and corrective actions taken.
• Develop and approve PQ protocols that outline the tests to be performed to verify equipment performance under actual production conditions.
• Conduct tests to ensure the equipment consistently performs according to specifications.
• Develop and conduct training programs for staff on IQ/OQ/PQ procedures and protocols.

Benefits

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

What This Job Offers

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