Description

You will develop, execute, and repair IQ, OQ, and PQ protocols for equipment and systems in a regulated manufacturing environment.

This role is on-site.

Responsibilities

• Conduct risk assessments and develop qualification strategies for new and existing equipment.
• Analyze and interpret qualification data to ensure accuracy, completeness, and regulatory compliance.
• Collaborate with Process Engineering, Quality, and Manufacturing teams to execute qualification activities and meet project milestones.
• Maintain comprehensive qualification documentation, ensuring traceability and accessibility for audits and inspections.
• Provide training and guidance to manufacturing and quality personnel on qualification processes.

Required Skills

• Bachelor’s degree in Engineering or Life Sciences required.
• 5+ years of experience in regulated manufacturing environments (medical device, pharmaceutical, or biotechnology).
• Strong technical writing skills for protocol development and reporting.
• Proven experience executing IQ, OQ, and PQ qualification activities.
• Ability to analyze data and solve complex technical problems.
• Knowledge of FDA, ISO, and other relevant regulatory guidelines.

Key Skills

Education

Bachelor's degree