Daily Administration: Utilize SAP daily to log, update, track, and close out work orders, PM tasks, and calibration records with complete technical accuracy and traceability.
Equipment Reliability & PM / Calibration Procedure Optimization in MasterControl
Reliability Analysis: Analyze failure modes, downtime metrics, calibration out-of-tolerance (OOT) events, and execution history to proactively identify opportunities to improve long-term equipment reliability.
Procedure Optimization: Evaluate and optimize both Preventive Maintenance (PM) and Calibration procedures, routines, tolerances, and frequencies to eliminate redundant, ineffective, or non-value-added steps.
Document Ownership in MasterControl: Author, revise, and shepherd actual procedural document updates through MasterControl, driving cross-functional reviews and approvals in full compliance with site QMS guidelines.
Maintenance Shop Management & Spare Parts Inventory Control
Spare Parts & Inventory Management: Oversee and maintain proper stock levels of critical spare parts, components, and consumables in the maintenance shop to support business operational needs without delay.
Procurement & Kanban Control: Order replacement materials, manage vendor/parts staging, and establish/maintain structured inventory systems such as Kanban or lean visual controls.
PM Kit Assembly & Shop Organization: Build, stage, and organize pre-assembled PM kits for scheduled maintenance events to streamline work execution and minimize equipment downtime.
Execution of PMs, Calibrations & General Maintenance
Compliant Execution: Execute scheduled Preventive Maintenance (PM) and routine Calibrations on complex automated manufacturing equipment in full compliance with SOPs, QMS, and regulatory guidelines.
Documentation Excellence: Ensure all execution records, calibration certificates, and logbooks adhere strictly to Good Documentation Practices (GDP) and real-time documentation standards.
Preventive Diagnostics: Perform routine inspections and diagnostic tests on equipment to prevent unplanned production interruptions.
Cross-Functional Collaboration, Troubleshooting & Flexible Support
Cross-Functional Collaboration: Build strong, positive working relationships with Production, Quality, MSAT, Facilities, and Automation teams to ensure seamless operational support and alignment.
Service Mindset: Demonstrate high emotional intelligence, approachable communication, and a service mindset when collaborating with cross-functional partners to solve operational issues.
Equipment Troubleshooting: Investigate, troubleshoot, and perform corrective maintenance on complex automated manufacturing equipment, mechanical assemblies, and electrical control systems.
Flexible Operational Support: Maintain complete flexibility and a proactive “can-do” mindset to jump in and support urgent site maintenance needs, building priorities, and operational requests as assigned.
Protocols & Testing: Execute IQ/OQ protocols, cleanroom control protocols, and diagnostic experiments using specialized technical instruments.
EDUCATION & EXPERIENCE
Education: Bachelor’s Degree in Engineering, Industrial Maintenance, Mechatronics, or a related technical discipline required.
Industry Background: Proven track record in maintaining, troubleshooting, and calibrating automated manufacturing equipment in a regulated industry (Biotech, Pharma, or Medical Device preferred).
CMMS Project Experience: Direct experience leading or supporting CMMS (SAP) optimization and system improvement projects.
Shop & Inventory Control Experience: Experience with maintenance shop organization, spare parts ordering, inventory control (Kanban), and building PM kits.
QMS & Document Management: Demonstrated experience optimizing PM and calibration procedures and authoring technical documents in a formal system (MasterControl preferred).
TECHNICAL SKILLS & COMPETENCIES
Interpersonal & Collaborative Skills: Excellent team player with a proven ability to communicate clearly, build strong working relationships, and work constructively with partners across different departments.
CMMS & Inventory Engineering: Advanced technical capabilities in SAP (or equivalent CMMS) for system design improvements, spare parts management, Kanban inventory setup, and workflow optimization.
Reliability Engineering & Quality Systems: Strong ability to analyze equipment failure and calibration data, optimize PM and calibration strategies, and author compliant procedural updates in MasterControl under strict GDP standards.
Technical Troubleshooting: Hands-on mechanical, electrical, pneumatic, and automation engineering troubleshooting skills.
Adaptability & Ownership: Proactive attitude with high willingness to support shift priorities and broader team needs.
WORK ENVIRONMENT & PHYSICAL DEMANDS
Environment: Environmentally controlled cleanrooms, biotech laboratories, and maintenance workshop environments. May involve exposure to automated equipment, hazardous chemicals, or bloodborne pathogens following strict safety protocols.
Physical Demands: Frequently required to stand, walk, reach, bend, and lift or move equipment up to 35 lbs. Requires close vision, color vision, and depth perception to adjust and repair machinery.
