IQ/OQ/PQ Validation Engineer - On-site

Capgemini; Hopkinsville (KY); On-site; USD 29,000 - 45,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Retirement benefits

Job summary

Capgemini in Hopkinsville, KY seeks a Qualification Program Administrator to oversee IQ/OQ/PQ of equipment and systems in a regulated manufacturing setting. This on-site contract role ensures regulatory compliance, quality, and traceability across installations and validations.

You will develop IQ requirements, approve and execute IQ/OQ/PQ plans, document protocols, manage deviations, and generate a comprehensive quality summary report.

Qualifications

• Bachelor’s degree in engineering, Life Sciences, or a related field is required.
• 3–5 years of experience in equipment qualification or validation in a regulated industry.
• Strong knowledge of IQ/OQ/PQ processes and regulatory standards.
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills.
• Experience with cGMP and FDA regulations.
• Proficiency in data analysis and reporting tools.
• Flexible with working hours per production floor availability.
• Open to travel.
• Ability to work collaboratively with cross-functional teams.

Responsibilities

• Establish clear IQ requirements aligned with standards and regulatory expectations.
• Obtain approval for the IQ protocol before implementation.
• Execute IQ processes in accordance with the approved protocol.
• Document IQ protocol accurately and in compliance with standards.
• Conduct post-protocol reviews to assess effectiveness and compliance.
• Ensure completion and verification of IQ processes with quality standards.
• Provide a comprehensive summary of IQ activities and outcomes.
• Initiate and review OQ requirements and plan.
• Obtain approval for the OQ plan before execution.
• Execute the OQ and Test Plan as approved.
• Verify OQ training and competency of personnel.
• Verify OQ of equipment and calibration.
• Identify and document deviations during OQ and implement corrective actions.
• Record and resolve deviations, re-executing failed portions if needed.
• Document the OQ protocol thoroughly.
• Complete all OQ requirements and approvals.
• Review and approve the OQ protocol prior to execution.
• Create a detailed Quality Summary Report for IQ and OQ.
• Initiate and review PQ requirements and approve the PQ plan.
• Execute the PQ protocol and tests as planned.
• Perform process verification during PQ.
• Complete PQ and verify outcomes.

Skills

IQ/OQ/PQ knowledge

Analytical skills

Communication skills

cGMP/FDA regulations

Data analysis tools

Cross-functional collaboration

Travel willingness

Education

Bachelor’s degree in engineering, Life Sciences, or a related field

Job description

Capgemini in Hopkinsville, KY seeks a Qualification Program Administrator to oversee IQ/OQ/PQ of equipment and systems in a regulated manufacturing setting. This on-site contract role ensures regulatory compliance, quality, and traceability across installations and validations.

You will develop IQ requirements, approve and execute IQ/OQ/PQ plans, document protocols, manage deviations, and generate a comprehensive quality summary report.