C&Q Engineer

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

Hopkinsville, KY, United States (On-site)

Contract (10 months 28 days)

Published 2 days ago

Quality Assurance

Cross - Functional Coordination

Deviation management

regulatory and compliance

Performance Qualification

The Qualification Program (IQ/OQ/PQ) Administrator 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.

Key Responsibilities:

• Establish clear and comprehensive Information Quality (IQ) requirements, ensuring accuracy, completeness, and alignment with organizational and regulatory standards.
• Obtain approval for the Information Quality (IQ) protocol, ensuring it meets all necessary standards, compliance requirements, and project objectives before implementation.
• Execute the Information Quality (IQ) processes, ensuring all actions are carried out according to the approved protocol and meet quality and regulatory standards.
• Document the Information Quality (IQ) protocol thoroughly, ensuring accuracy, clarity, and compliance with organizational and regulatory standards.
• Conduct a post-protocol review to assess the effectiveness of the Information Quality (IQ) protocol, ensuring it met the intended goals and compliance requirements.
• Ensure the completion of all Information Quality (IQ) processes, verifying that all steps are executed and meet established quality and compliance standards.
• Provide a comprehensive summary of Information Quality (IQ) activities, highlighting key actions, outcomes, and adherence to quality and regulatory standards.
• Initiate and review Operational Qualification (OQ) requirements, ensuring they align with project goals and comply with regulatory and quality standards.
• Obtain approval for the Operational Qualification (OQ) plan, ensuring it meets all necessary quality standards and regulatory requirements before execution.
• Execute the Operational Qualification (OQ) and Test Plan, ensuring all tests are carried out according to the approved plan and meet the required performance and quality standards.
• Ensure the completion and verification of Operational Qualification (OQ) training, confirming that all personnel are adequately trained and meet the required competencies and standards.
• Verify the Operational Qualification (OQ) of equipment, ensuring it meets specified standards, is properly calibrated, and complies with regulatory and quality requirements.
• Identify and document any deviations during the Operational Qualification (OQ) process, ensuring that corrective actions are taken to maintain compliance and quality standards.
• Record and resolve deviations identified during the Operational Qualification (OQ) process, ensuring timely corrective actions are implemented and documented to maintain compliance with quality standards.
• Re-execute any failed portions of the Operational Qualification (OQ) process, ensuring that all tests meet the required standards and compliance is achieved.
• Document the Operational Qualification (OQ) protocol thoroughly, ensuring clarity, accuracy, and compliance with established standards and regulatory requirements.
• Ensure the completion of all Operational Qualification (OQ) requirements, confirming that all criteria are met and documented in accordance with regulatory and quality standards.
• Review and approve the Operational Qualification (OQ) protocol, ensuring it meets all necessary quality and regulatory standards before execution.
• Create a detailed Quality Summary Report for IQ and OQ processes, ensuring all findings, compliance levels, and deviations are accurately documented and aligned with project standards.
• Initiate and review Performance Qualification (PQ) requirements, ensuring they align with project objectives and meet established quality and regulatory standards.
• Approve the Performance Qualification (PQ) plan, ensuring it meets all necessary quality standards and regulatory requirements before execution.
• Execute the Performance Qualification (PQ) protocol, ensuring all tests and procedures are carried out in accordance with the plan and meet the required performance and quality standards.
• Perform process verification during the Performance Qualification (PQ) phase, ensuring that all processes meet the specified performance criteria and comply with quality standards.
• Ensure the completion and verification of Performance Qualification (PQ) tr

Required Skills & Experience:

• Bachelor’s degree in engineering, Life Sciences, or a related field.
• 3-5years 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 as per production floor availability.
• Open to travel
• Ability to work collaboratively with cross-functional teams.
• Strong communication and interpersonal skills.
• Experience with cGMP and FDA regulations.
• Proficiency in data analysis and reporting tools.
• Flexible with working hours as per production floor availability.
• Open to travel
• Ability to work collaboratively with cross-functional teams.

The pay range that the employer in good faith reasonably expects to pay for this position is $20.80/hour - $32.51/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.

Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.