C&Q Engineer

Vivid Soft Global; Hopkinsville (KY); On-site; USD 85,000 - 120,000; Full time

Job summary

Vivid Soft Global Inc in Hopkinsville, KY, onsite role responsible for overseeing IQ/OQ/PQ qualification of equipment and systems to meet regulatory and quality standards.

You will establish IQ requirements, obtain protocol approvals, run IQ/OQ/PQ activities, and document protocols and deviations.

The position requires a bachelor’s degree in engineering or life sciences, 3–5 years in qualification/validation, knowledge of cGMP and FDA regulations, and willingness to travel.

Qualifications

• Bachelor’s degree in engineering or life sciences (or related field).
• 3–5 years of experience in equipment qualification or validation in a regulated industry.
• Strong knowledge of IQ/OQ/PQ processes and regulatory standards.
• Experience with cGMP and FDA regulations.
• Proficiency in data analysis and reporting tools.

Responsibilities

• Establish clear and comprehensive Information Quality (IQ) requirements.
• Obtain approval for the IQ protocol before implementation.
• Execute the IQ, OQ, and PQ processes per approved plans.
• Document IQ/OQ/PQ protocols and deviations.
• Create a detailed Quality Summary Report for IQ and OQ processes.
• Review and approve OQ and PQ plans and protocols.
• Provide training verification for OQ activities.

Skills

IQ/OQ/PQ processes

cGMP

FDA regulations

Data analysis

Analytical skills

Communication skills

Cross-functional teamwork

Travel willingness

Education

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

Job description

Work Location: Hopkinsville, Kentucky (Onsite) - Need Locals

Contract

JOB DESCRIPTION

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)

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.