Lead Electrical and Instrumentation Technician

Overview: We are seeking highly skilled and qualified Lead Instrumentation and Electrical Technician to serve as a cornerstone of maintenance for our clinical and commercial production efforts at our CRDMO facility in Middletown, DE. A multi-craft expert who excels in complex maintenance management systems and front-line troubleshooting, across a wide variety of equipment and regulatory requirements. Reporting to the Electrical Controls and Equipment Maintenance Manager, this individual will lead the execution of maintenance on critical plant utilities, manufacturing and facilities equipment. The ideal candidate will perform as a primary subject matter expert on instrumentation and electrical systems for Maintenance, Facilities and Engineering while ensuring optimum performance of site assets.

Responsibilities

• Maintenance Execution: Utilize and manage Computerized Maintenance Management System. Perform preventive/predictive and corrective Maintenance work in coordination with production, EHS, Facilities and Engineering.
• Multi-Craft Maintenance: Perform routine and corrective maintenance on utilities equipment, including Boilers, Chillers, Cooling Towers, Air Compressors, Process Water Systems, Generators etc.
• Technical "First Responder": Perform hands-on adjustments and repairs to instrumentation and electrical equipment to prevent product impact and downtime.
• Contractor Oversight: Provide on-site escort and technical supervision for specialized vendors. Execute permitting procedures and coordinate daily maintenance/operational tasks.
• Hybrid Maintenance: Work in collaboration with utility/facility technical staff, process engineering team, EHS, Production and 3rd party contractors/resources to support the execution of work orders in various environments.
• Client Interaction: Support client site visits and onsite audits by demonstrating technical mastery of processes and environment.
• Consumables Management: Manage complex inventory of consumables, single-use assemblies, sensors, and filters required for planned and corrective maintenance.
• Cleaning and Sanitization: Participate in the execution of operational procedures and adhere to all current Good Manufacturing Practices.
• Safety and Compliance: Ensure all maintenance activities are performed in accordance with WuXi EHS policies.
• Process Improvement: Progressively identify and propose Continuous Improvements to equipment or workflows that enhance yield, reduce ergonomic strain, decrease setup time, etc.

Regulatory Compliance and Documentation

• Good Documentation Practices: Execute and review documentation in real-time. Ensure compliance with attributable, legible, contemporaneous, original and accurate input.
• Deviation Management: Act as the primary technical witness and Subject Matter Expert for process deviation investigations; assist Quality Assurance in conducting Root Cause Analysis and implementing corrective actions.
• Validation: Support the execution of validation protocols for new manufacturing technologies and equipment.
• Audit Readiness: Maintain the production suites in a constant state of "inspection readiness" for FDA, DEA, internal and client-led quality audits.
• Standard Operating Procedures: Lead the drafting and periodic review of SOPs and Drawings, ensuring they reflect current Good Manufacturing Practices.
• Support Maintenance Management during regulatory audits by retrieving logs and explaining maintenance histories.

Team Leadership and Training

• Floor Leadership: Provide technical guidance to maintenance personnel during assigned work activities. Provide clear direction on safety and task prioritization. Support the execution of Safe Work Permitting and Hazardous Energy Control Procedures.
• Technical Mentorship: Provide technical training and mentoring to technician staff, while continuing to perform hands-on maintenance activities. Serve as the site's technical resource for instrumentation and electrical systems in preventive, predictive, and corrective maintenance.
• Cross-Functional Collaboration: Pro-active collaboration with Production, Engineering, Quality, EHS and Facilities to ensure safe and efficient operation.
• Culture Champion: Foster a culture of "Right First Time" and continuous improvement.

Continuous Improvement and Cost Management

• Waste Reduction: Monitor and reduce waste of raw materials, consumables and spare parts.
• Overall Effectiveness: Support the tracking of Equipment Effectiveness and provide feedback on bottlenecks, Key Performance Indicators and data collection techniques.
• Lean Initiatives: Suggest and Implement cost saving initiatives.
• EHS: Support Environment, Health and Safety through participation in the site Emergency Response Program.
• Participate in Root Cause Analysis (RCA)meetings to prevent the recurrence of mechanical failures.

Qualifications

• High School Diploma or GED
• 6 years’ Industrial/Pharmaceutical Maintenance Experience. Experience in the electrical and instrumentation fields preferred.
• Technical Proficiency: Multi-craft troubleshooting abilities (pumps, motors, valves, Air Handlers, HVAC, Boilers, Chillers). Able to interpret and work from a broad spectrum of drawing types.
• GMP Knowledge: Demonstrated understanding of working in cleanroom environments and following strict gowning and documentation protocols.
• System Experience: Familiarity with Process Control Systems, Building Automation Systems and Environmental Monitoring Systems.
• Software: Basic proficiency in computer technologies, Microsoft Office and experience using modern data acquisitions systems/historians. Experienced user of computerized maintenance management systems.
• Communication/Technical Writing: Ability to clearly and professionally communicate technical issues to non-technical stakeholders in-person and through electronic communications. Able to proficiently write technical subject matter for communications with maintenance, facilities and engineering staff.
• Licensing: Journey person Electrical License Preferred.