Lead Maintenance Mechanic

WuXi Chemistry; Town of Middletown (NY); On-site; USD 85,000 - 105,000; Full time

Job summary

WuXi Chemistry in Middletown, DE seeks a Lead Maintenance Mechanic to serve as the technical expert for utilities and facility systems in a cGMP pharmaceutical environment. You will lead preventive/predictive maintenance, troubleshoot complex equipment, and ensure safe, continuous operation of critical plant infrastructure.

You will collaborate with Production and Quality teams, supervise contractors on-site, manage spare parts, and drive continuous improvements to reduce downtime and improve

Qualifications

• 3+ years of hands-on maintenance in Pharma/Biotech or regulated environment.
• Strong mechanical/electrical troubleshooting skills (pumps, motors, valves, AHUs, Boilers, Chillers).
• GMP knowledge and experience working in cleanroom environments.
• Experience with CMMS and building control systems.
• Ability to clearly communicate technical issues to non-technical stakeholders.

Responsibilities

• Monitor and maintain water purification, clean steam, and HVAC systems using BMS/EM systems.
• Perform Preventative/Predictive Maintenance and assist with diagnostics.
• Serve as first responder for utility alarms and equipment failures.
• Oversee contractors and ensure proper documentation and permitting procedures.
• Document all maintenance activities in CMMS with detail for compliance.
• Collaborate with Production and Quality to align equipment availability with manufacturing needs.

Skills

Pumps

Motors

Valves

AHUs

Boilers

Chillers

MV Control Logic

CMMS experience

GMP knowledge

Documentation writing

Education

High School Diploma or GED

Tools

CMMS

Building control systems

Job description

Overview: We are seeking a highly skilled and proactive Lead Maintenance Mechanic to serve as the primary technical expert for the operation and maintenance of utilities and facility systems at our pharmaceutical manufacturing facility in Middletown, DE. Reporting to the Electrical Control & Equipment Maintenance Manager, this multi-craft role combines advanced maintenance strategies and mechanical troubleshooting with the rigorous documentation standards of the cGMP environment. The successful candidate will be responsible for the execution of preventive/predictive maintenance, troubleshooting complex equipment failures, and ensuring the continuous, safe operation of critical plant infrastructure to support life-saving production goals.

Responsibilities

• Critical Utilities: Monitor & maintain water purification systems, clean steam generators and HVAC utilizing Building Management & Environmental Monitoring Systems.
• Reliability Execution: Execute Preventative/Predictive Maintenance tasks, including assisting with thermography, vibration analysis, data collection, oil sampling etc.
• Emergency Response: Serve as first responder for utility alarms and equipment failures.
• Contractor Oversight: Provide on-site escort and technical over-the-shoulder supervision for specialized vendors. Execute permitting procedures & coordinate daily maintenance/operational tasks.
• Complete work orders in the CMMS with high detail, ensuring all parts used and tasks performed are documented for regulatory compliance.
• Spare Parts & Tooling Management: Maintain the physical organization of the utilities shop and spare parts inventory; identify and request restock of critical components.
• Safety Leadership: Actively participate Hazardous Energy Control Procedures & Lock-out/Tag-out program. Execute Safe Work Permitting for contractors.
• System Optimization/Energy Management: Assist the maintenance management in identifying equipment trends or recurring failures and suggest mechanical or operational “Continuous Improvements”.
• Process Improvement: Progressively identify and propose Continuous Improvements to equipment or workflows that enhance yield, reduce ergonomic strain, decrease setup time, etc.

Regulatory Compliance & Documentation

• Good Documentation Practices: Execute and review documentation in real-time. Ensure compliance with attributable, legible, contemporaneous, original and accurate input.
• Capture & maintain accurate records of all maintenance activities, work orders, SOPs, calibration, and validation reports through the CMMS.
• Assist in the execution of qualification and validation protocols for new facilities/utilities equipment.
• Support Maintenance Management during regulatory audits by retrieving logs and explaining maintenance histories.
• Standard Operating Procedures: Lead the drafting and periodic review of SOPs & Drawings, ensuring they reflect current Good Manufacturing Practices.
• Audit Readiness: Maintain the production suites in a constant state of "inspection readiness" for FDA, DEA, internal and client-led quality audits.
• Serve as a technical mentor as the maintenance team expands, providing on-the-job training to junior personnel.
• Collaborate daily with Production and Quality teams to ensure equipment availability aligns with the manufacturing needs.
• Assist in the drafting and "red-lining" of Standard Operating Procedures & As-Built Drawings.
• Collaborate & Coordinate with Vendors for Equipment Specific Training.
• Participate in the execution of change controls.
• Identify opportunities for energy reduction & continuous improvement. (ex. Identifying/Repairing Leaks, optimizing chiller sequences, improving maintenance-operations sequences).
• Participate in Root Cause Analysis (RCA)meetings to prevent the recurrence of mechanical failures.
• Support the implementation of the computerized maintenance management system by providing accurate field data and feedback on system operability.
• Provide technical subject matter expertise on equipment & consumables. Address standardization and identify cost saving opportunities.
• Support Environment, Health & Safety through active participation in the Emergency Response Program.

Qualifications

• High School Diploma or GED
• 3+ years of hands-on maintenance experience in a Pharmaceutical, Biotechnology, or highly regulated industrial environment.
• Technical Proficiency: Strong mechanical/electrical troubleshooting skills (pumps, motors, valves, AHUs, Boilers, Chillers, 480V/3-phase distribution and Medium Voltage control logic).
• GMP Knowledge: Demonstrated understanding of working in cleanroom environments and following strict gowning and documentation protocols.
• System Experience: Familiarity with building control systems and interfacing equipment.
• Software: Basic proficiency in Microsoft Office and experience using a Computerized Maintenance Management System (CMMS).
• Communication/Technical Writing: Ability to clearly & professionally communicate technical issues to non-technical stakeholders in-person & through electronics communications. Able to proficiently write technical subject matter for communications with engineering.