Maintenance Engineer
Listed on 2026-10-08
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Engineering
Quality Engineering, Maintenance Technician / Mechanic, Process Engineer
Role:
Maintenance Engineer supporting engineering and facilities operations within a cGMP biotech environment, focusing on equipment reliability, preventive maintenance, and utility systems.
Responsibilities: develop and optimize maintenance programs, lead maintenance and utility projects, ensure compliance and safety, troubleshoot complex systems, and drive continuous improvement initiatives including SOP development, root cause analysis, and reliability enhancements. Core collaboration with manufacturing, quality, validation, and EHS teams.
Requirements: associate degree in Engineering, Life Sciences, or related field; minimum 6 years supporting manufacturing equipment, facilities, or utility systems in regulated environments; expertise in maintenance, reliability principles, root cause analysis, and cGMP documentation.
Preferred:
Bachelor's degree; experience with CMMS (Blue Mountain Ram
4), AutoCAD, and GMP documentation.
High Value: biotech manufacturing, equipment reliability, clean utility systems, cGMP compliance, root cause analysis, SOP and change control authoring, cross-functional collaboration.
Work Setup: onsite Durham, NC; flexible hours with potential for additional shifts.
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