Equipment Qualification Engineer

Planet Pharma Group; Concord (OH); In loco; USD 85.000 - 110.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

IQ/OQ Protocols

Validation & Compliance

Environmental Mapping

Deviation Management

CAPA Development

GxP Regulations

Risk Assessments

Technical Documentation

Cross-Functional Coordination

Formazione

Bachelor’s degree in Engineering or Life Sciences

Descrizione del lavoro

Our client, a growing pharmaceutical manufacturing organization, is seeking an experienced Equipment Qualification Engineer to support qualification and validation activities within a cGMP-regulated production environment. This individual will play a key role in ensuring manufacturing equipment and controlled environments remain compliant and inspection-ready through the execution of qualification, requalification, and environmental mapping activities.

This position offers the opportunity to collaborate closely with Engineering, Quality, Manufacturing, and Facilities teams while supporting critical operational and compliance initiatives.

Responsibilities

Equipment Qualification

• Develop, review, and execute Installation Qualification (IQ) and Operational Qualification (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.

Requalification & Compliance

• 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.

Environmental Mapping

• 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.

Qualifications

Required

• 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.

Preferred

• Experience supporting pharmaceutical, biotechnology, API, medical device, or other FDA-regulated manufacturing environments.
• Background in environmental mapping, utility qualification, or facility validation activities.
• Experience working directly with manufacturing floor equipment and process systems.
• Ability to collaborate effectively across Engineering, Quality, Facilities, and Operations teams.

Key Skills

• Equipment Qualification (IQ/OQ)
• Validation & Compliance
• Environmental Mapping
• Deviation Management
• CAPA Development
• cGMP / GxP Regulations
• Risk Assessments
• Technical Documentation
• Cross-Functional Project Coordination