Planet Pharma
From Planet Pharma's careers page
Status: listed on the employer's own careers page when we last checked (daily). Confirm on their site before applying.
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.
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.
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.
Knowledge of cGMP regulations and validation lifecycle requirements.
Familiarity with deviation investigations, CAPAs, and change control processes.
Strong organizational, communication, and project coordination skills.
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.
Equipment Qualification (IQ/OQ)
Validation & Compliance
Environmental Mapping
Deviation Management
CAPA Development
cGMP / GxP Regulations
Risk Assessments
Technical Documentation
Cross-Functional Project Coordination
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