Senior Equipment Qualification Engineer (IQ/OQ, Validation)

Planet Pharma; Concord (OH); On-site; USD 85,000 - 110,000; Full time

Job summary

Planet Pharma is seeking an experienced Equipment Qualification Engineer to support qualification, validation, and environmental mapping in a cGMP manufacturing setting. You will develop IQ/OQ protocols, perform field verifications, execute testing, and maintain compliant qualification records while collaborating with Engineering, Quality, Manufacturing, and Facilities teams.

The role requires strong project coordination, experience with deviations and CAPA, and a proactive approach to ensuring

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• 3-5 years of experience in equipment qualification, validation, or commissioning within a regulated manufacturing environment.
• Experience developing and executing IQ/OQ protocols.
• Knowledge of cGMP regulations and validation lifecycle requirements.
• Familiarity with deviation investigations, CAPAs, and change control processes.
• Strong organizational, communication, and project coordination skills.

Responsibilities

• Develop, review, and execute IQ and OQ protocols for manufacturing and production equipment.
• Perform field verification activities to ensure equipment installations align with engineering specifications, drawings, vendor documentation, and user requirements.
• Execute operational and functional testing to verify equipment performance and compliance with validation requirements.
• Support qualification documentation, protocol approvals, and final reports.
• Conduct periodic reviews and requalification assessments to maintain validated system status.
• Identify, investigate, and document deviations encountered during qualification activities.
• Partner with Quality and Operations teams to support investigations, root cause analysis, and CAPA development.
• Maintain qualification records and ensure compliance with applicable GxP and regulatory requirements.
• Execute temperature and humidity mapping studies for controlled environments, including manufacturing, warehouse, storage, stability, and laboratory support areas.
• Analyze mapping data and prepare summary reports to support ongoing compliance.
• Assist with environmental monitoring and qualification activities related to controlled storage and processing areas.

Skills

IQ/OQ Protocols

Validation & Compliance

Environmental Mapping

Deviation Management

CAPA Development

GxP Regulations

Risk Assessments

Technical Documentation

Cross-Functional Coordination

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

Planet Pharma is seeking an experienced Equipment Qualification Engineer to support qualification, validation, and environmental mapping in a cGMP manufacturing setting. You will develop IQ/OQ protocols, perform field verifications, execute testing, and maintain compliant qualification records while collaborating with Engineering, Quality, Manufacturing, and Facilities teams.

The role requires strong project coordination, experience with deviations and CAPA, and a proactive approach to ensuring