IQ/OQ/PQ Validation Engineer - Onsite

Vivid Soft Global Inc; 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

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.