Manufacturing Equipment Qualification (IQ/OQ/PQ) Engineer
Capgemini · McLean, VA · 1 mo ago
Management$69k–$162k/yrFull-time
Location: Richmond, Virginia
About the role
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.
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 Operational Qualification (OQ) protocols that outline the tests to be performed to verify equipment operation.
- Conduct OQ 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 Performance Qualification (PQ) protocols that outline the tests to be performed to verify equipment performance under actual production conditions.
- Conduct PQ tests to ensure the equipment consistently performs according to specifications.
- Develop and conduct training programs for staff on IQ/OQ/PQ procedures and protocols.
Requirements
- Minimum of 3 years of relevant 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.
- U.S. citizenship or Green Card holder.
Pay
The base compensation range for this role in Richmond, Virginia is $68,911 – $161,544. In addition to base salary, the role may be eligible for variable incentives, bonuses, or commissions, depending on the position and applicable laws.
Benefits
- Paid time off based on employee grade (A‑F): Vacation 12‑25 days, company‑paid holidays, personal days, and 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.