Lead Instrumentation Technician

Role Summary

Lead Instrumentation Technician role at Lilly's API manufacturing startup site in Lebanon, IN. Accountable for the sustainability of the instrumentation maintenance strategy, serving as the first-line response to instrumentation reliability issues, providing field support to identify, troubleshoot, and resolve malfunctions, and training new Instrumentation Technicians. Will take an acting lead role on major projects and support the startup into GMP manufacturing operations.

Responsibilities

• Support a safety-first, quality-always maintenance team.
• Ability to respond quickly and proactively to changing priorities within a reasonable timeframe.
• Cross-functional collaboration with Global Facility Delivery (GFD) to support project delivery.
• Support C&Q activities, including but not limited to initial calibrations, shakedowns, initial/operational verification, and/or equipment qualification.
• Work with or supervise contractors performing calibration of instruments.
• Perform preventive and corrective maintenance and calibration on process instrumentation, temperature, pressure, flow and automatic control valves.
• Troubleshoot and diagnose process instrumentation equipment problems and make appropriate repairs to minimize downtime.
• Perform modifications and new installations of process instrumentation.
• Support Engineering with: redesign, updating, and/or specifying instruments; ensuring process instrumentation is in control, capable, and compliant to be used to manufacture API drug substances; and creation and development of RCFA, FMEA, RCM, PHR, etc.
• Contribute to incident/deviation investigations on instrumentation and implement countermeasures to prevent recurrence.
• Complete assigned Trackwise / CAPA items in a timely manner.
• Own change controls, when applicable, to increase instrumentation robustness and reliability.
• Oversee the Secondary Standards program, including instrument calibration procedures and tolerances based on measurement uncertainty analysis.
• Act as SME in the site calibration program.
• Make improvement recommendations for instrument calibration practices or instrument shop standards to ensure CPP measurements comply with corporate standards.

Qualifications

• Experience: Minimum of three years in a manufacturing-site instrument technician role.
• Authorized to work in the United States on a full-time basis.

Education

• Associate’s degree in electrical / Automation / Instrumentation, or equivalent experience.

Skills

• Supports a flexible 24/7 schedule.
• Willing to support off-hour emergencies when necessary.
• Mentoring skills to educate craftspeople on new instrumentation technologies.
• Ability to read and understand P&ID drawings and schematics.
• Thorough understanding of calibration concepts and requirements including accuracy testing requirements.
• Thorough understanding and application of GMPs and FDA regulations.
• Thorough understanding and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities, and laboratory environments.
• Effective communication and problem-solving skills with clients and coworkers.

Additional Requirements

• Tasks require entering manufacturing areas; PPE required.
• May be required to provide support outside of normal working hours including nights, weekends, and holidays.
• Travel less than 5% of the time.
• Schedule: This position is Monday–Friday; future shift to be discussed; must be available for off-hour support; overtime may be required.