Lead Maintenance Specialist
Job in
Morrisville, Wake County, North Carolina, 27560, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Maintenance/Cleaning
Job Description & How to Apply Below
Role:
Maintenance Specialist ensuring GMP-compliant operation and lifecycle management of manufacturing equipment, facilities, and utilities in a biopharma manufacturing setting.
- oversee asset turnover
- participate in commissioning, qualification, and startup
- optimize preventive and predictive maintenance programs
- coordinate maintenance across HVAC, utilities, process, and laboratory equipment
- manage vendor activities and ensure documentation compliance
- support regulatory audits and investigations
- drive continuous improvement and reliability initiatives
- B.S. in Engineering or related field with 8+ years of relevant experience, or high school diploma with 12+ years in pharmaceutical facilities maintenance
- experience with CMMS platforms (e.g., Maximo, SAP PM)
- knowledge of GMP, FDA 21 CFR Parts 210, 211, Part 11, and validation processes
- familiarity with CQV, ISPE guidelines, reliability-centered maintenance, and predictive maintenance tech
- strong maintenance and reliability knowledge, project management, troubleshooting, stakeholder collaboration, and documentation skills
- GMP pharmaceutical manufacturing, utilities and facilities management, compliance with regulatory standards, support for audits and validations, and work in a GMP environment
Location/work setup and travel details are not specified.
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