Maintenance Engineer

Job Description

Carlsbad, CA

1 year contract, potential for extension or conversion

SHIFT: M-F 6am-2:30pm, 1st shift

POSITION SUMMARY

The Maintenance Engineer I will drive site equipment reliability, system uptime, and operational readiness across manufacturing processes. This role focuses on the active administration and continuous engineering improvement of our CMMS (SAP) platform, alongside optimizing both preventive maintenance (PM) and calibration procedures to maximize asset performance. Operating in a highly collaborative, cross-functional environment, this engineer must possess exceptional interpersonal skills to build strong working relationships across operations, quality, and engineering teams. Additionally, this role oversees maintenance shop operations, ensuring inventory control, spare parts availability, ordering, Kanban implementation, and PM kit assembly to support seamless execution. This position is responsible for leading CMMS system enhancement projects, driving document and procedure updates in MasterControl, executing compliant PMs and calibrations, and maintaining a flexible mindset to support site maintenance needs as they arise.

POSITION REQUIREMENTS & PRIMARY RESPONSIBILITIES

CMMS (SAP) Engineering & System Improvement Projects

Lead Engineering Projects: Drive initiatives aimed at enhancing and optimizing the CMMS (specifically SAP) structure, master data, maintenance workflows, and reporting tools.

Process & Data Optimization: Drive system improvement initiatives to optimize spare parts inventory management, Bill of Materials (BOM) accuracy, PM/calibration task lists, and work-order management processes.

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.