Lead Electrical and Instrumentation Technician
About the role
We are seeking a 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
- Utilize and manage the Computerized Maintenance Management System to perform preventive, predictive, and corrective maintenance in coordination with Production, EHS, Facilities, and Engineering.
- Perform routine and corrective maintenance on utilities equipment, including boilers, chillers, cooling towers, air compressors, process water systems, generators, and more.
- Act as a technical "first responder" by performing hands-on adjustments and repairs to instrumentation and electrical equipment to prevent product impact and downtime.
- Provide on-site escort and technical supervision for specialized vendors, execute permitting procedures, and coordinate daily maintenance and operational tasks.
- Work collaboratively with utility/facility technical staff, process engineering teams, EHS, Production, and third-party contractors to support work order execution in various environments.
- Support client site visits and onsite audits by demonstrating technical mastery of processes and environment.
- Manage a complex inventory of consumables, single-use assemblies, sensors, and filters required for planned and corrective maintenance.
- Participate in the execution of operational procedures and adhere to all current Good Manufacturing Practices (cGMP).
- Ensure all maintenance activities comply with WuXi EHS policies and regulatory requirements.
- Identify and propose continuous improvements to equipment or workflows to enhance yield, reduce ergonomic strain, decrease setup time, and improve overall efficiency.
- Execute and review documentation in real-time, ensuring compliance with attributable, legible, contemporaneous, original, and accurate input (Good Documentation Practices).
- Act as the primary technical witness and subject matter expert for process deviation investigations, assisting Quality Assurance in root cause analysis and corrective actions.
- Support the execution of validation protocols for new manufacturing technologies and equipment.
- Maintain production suites in a constant state of "inspection readiness" for FDA, DEA, internal, and client-led quality audits.
- Lead the drafting and periodic review of SOPs and drawings to ensure they reflect current Good Manufacturing Practices.
- Support Maintenance Management during regulatory audits by retrieving logs and explaining maintenance histories.
- Provide technical guidance to maintenance personnel during assigned work activities, including direction on safety and task prioritization.
- Support the execution of Safe Work Permitting and Hazardous Energy Control Procedures.
- Provide technical training and mentorship 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.
- Collaborate proactively with Production, Engineering, Quality, EHS, and Facilities to ensure safe and efficient operations.
- Foster a culture of "Right First Time" and continuous improvement.
- Monitor and reduce waste of raw materials, consumables, and spare parts.
- Support the tracking of Equipment Effectiveness and provide feedback on bottlenecks, Key Performance Indicators, and data collection techniques.
- Suggest and implement cost-saving initiatives and lean improvements.
- 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 of Industrial/Pharmaceutical Maintenance Experience; experience in electrical and instrumentation fields preferred.
- Multi-craft troubleshooting abilities (pumps, motors, valves, air handlers, HVAC, boilers, chillers).
- Able to interpret and work from a broad spectrum of drawing types.
- Demonstrated understanding of working in cleanroom environments and following strict gowning and documentation protocols (GMP knowledge).
- Familiarity with Process Control Systems, Building Automation Systems, and Environmental Monitoring Systems.
- Basic proficiency in computer technologies, Microsoft Office, and experience using modern data acquisition systems/historians.
- Experienced user of computerized maintenance management systems.
- Ability to clearly and professionally communicate technical issues to non-technical stakeholders in-person and through electronic communications.
- Proficient in writing technical subject matter for communications with maintenance, facilities, and engineering staff.
- Journeyperson Electrical License preferred.