Seeking a Facilities Engineer to support quality systems, environmental monitoring, facility systems, and inspection readiness within a regulated manufacturing environment.
Key Responsibilities
Lead investigations, CAPAs, NCs, deviations, and change controls related to facilities and environmental monitoring.
Support environmental monitoring systems, HVAC, utilities, cleanrooms, and facility compliance activities.
Develop and maintain SOPs, quality records, and compliance documentation.
Support audits, inspections, qualification/validation, and facility projects.
Partner with Facilities, Quality, Engineering, Validation, and Manufacturing teams.
Requirements
Bachelor's degree in Engineering or related technical discipline.
3+ years of experience in a regulated manufacturing environment.
Strong direct Quality experience with CAPA, deviations, investigations, and change controls.
Knowledge of GMP, FDA, and regulated manufacturing requirements.
Experience with environmental monitoring, HVAC, utilities, cleanrooms, or controlled environments.
Strong technical writing and root cause investigation skills.
Preferred: MedTech experience, ETQ/TrackWise/Veeva/MasterControl, CQV, environmental monitoring systems, and Lean Six Sigma.
Numbers & Facts
Location
NULL, MA
Salary
$45–$50
Skills
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Cleanroomunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Documentationunmatched
Environmental Monitoringunmatched
FDA (Food and Drug Administration)unmatched
Facilities Engineeringunmatched
GMP (Good Manufacturing Practices)unmatched
HVACunmatched
Lean Six Sigmaunmatched
Manufacturingunmatched
Manufacturing Requirementsunmatched
Medical Equipmentunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Root Cause Analysisunmatched
Standard Operating Procedures (SOP)unmatched
Systems Engineeringunmatched
Technical Writingunmatched
Writing Skillsunmatched
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