Qualification Engineer

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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.

• 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.

• 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.

The base compensation range for this role in the posted location is $68,911 to $137,821 / Annum. 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…