The Lead Tech of Instrumentation & Controls s responsible for the daily activities within the I&C and Metrology groups. This includes assigning and coordination of calibration and repair activities including project support, as needed across the site. The Lead ensures compliance with all applicable regulatory requirements, including Food & Drug Administration (FDA), current Good Manufacturing Practices (cGMP), and Occupational Safety and Health Administration (OSHA) regulations.

What You'll Do

• Leads a team of I&C technicians through troubleshooting and repairing equipment failures, conducting preventative maintenance, and performing equipment modifications and upgrades
• Develops and maintains calibration procedures, work instructions, and standard operation procedures (SOPs)
• Assists management with developing and maintaining the annual budget and schedule requirements
• Participates in budget forecasting for maintenance and capital projects
• Ensures I&C activities are carried out in a cost-effective manner
• Identifies opportunities to reduce costs and improve processes, and leads projects to implement improvements
• Evaluates, recommends, and selects new equipment purchases and upgrades with management
• Collaborates with other departments, such as production, quality control, process maintenance, and engineering, to ensure I&C activities support the overall goals of the site
• Partners with management and Reliability Engineers to develop and implement strategies to improve equipment reliability and to reduce downtown
• Enforces and ensures compliance with safety and cGMP quality standards
• Provides training and mentoring to other technicians
• Attends all required safety and health training
• Other duties, as assigned

Knowledge & Skills

• Advanced knowledge of mechanical, electrical, and control systems
• Knowledge of CMMS, TrackWise, and other computer based systems
• Strong analytical and problem-solving skills
• Effective communication, both written and oral
• Ability to work in a team environment
• Knowledge of lean manufacturing principles
• Ability to manage multiple priorities
• Ability to train or mentor others

Required Skills

• High School Diploma/GED with 8 years of I&C experience in a pharmaceutical or manufacturing environment
• Experience working in a GMP or another regulated environment
• Experience leading or providing oversight to technicians in a pharmaceutical or manufacturing industry

Preferred Skills

• Associate degree in Mechanical, Electrical, I&C, Chemical Engineering or a related field
• 9+ years of I&C experience in a pharmaceutical or manufacturing environment
• Experience with Computerized Maintenance Management System (CMMS), such as ProCalV5, Blue Mountain, Maximo, Infor EAM, etc.

Working Conditions & Physical Requirements:

Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. No X Yes May be required to operate a pallet jack
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. No X Yes 60 minutes
Ability to sit for prolonged periods of time. No X Yes 60 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 33 lbs., more with assistance
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes