Lead Maintenance Specialist

Role: Maintenance Specialist ensuring GMP-compliant operation and lifecycle management of manufacturing equipment, facilities, and utilities in a biopharma manufacturing setting. Responsibilities: 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. Requirements: 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. Preferred: familiarity with CQV, ISPE guidelines, reliability-centered maintenance, and predictive maintenance tech. Skills: strong maintenance and reliability knowledge, project management, troubleshooting, stakeholder collaboration, and documentation skills. HighValue: 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.