Equipment Qualification Engineer

Job Description

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.

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

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Responsibilities

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Equipment Qualification

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• Develop, review, and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols for manufacturing and production equipment.
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• Perform field verification activities to ensure equipment installations align with engineering specifications, drawings, vendor documentation, and user requirements.
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• Execute operational and functional testing to verify equipment performance and compliance with validation requirements.
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• Support qualification documentation, protocol approvals, and final reports.
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Requalification & Compliance

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• Conduct periodic reviews and requalification assessments to maintain validated system status.
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• Identify, investigate, and document deviations encountered during qualification activities.
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• Partner with Quality and Operations teams to support investigations, root cause analysis, and CAPA development.
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• Maintain qualification records and ensure compliance with applicable GxP and regulatory requirements.
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Environmental Mapping

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• Execute temperature and humidity mapping studies for controlled environments, including manufacturing, warehouse, storage, stability, and laboratory support areas.
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• Analyze mapping data and prepare summary reports to support ongoing compliance.
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• Assist with environmental monitoring and qualification activities related to controlled storage and processing areas.
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Qualifications

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Required

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

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

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