Team Lead, Engineering Maintenance

Role Summary

Team Lead, Engineering Maintenance manages a team of Maintenance technicians to support manufacturing continuously, efficiently, and effectively through maintenance activities (corrective, preventive). The role may require 1st or 2nd shift based on business needs. Location: onsite.

Responsibilities

• Adhere to quality policies and procedures to ensure products are safe, pure, effective, and of the highest quality.
• Perform a wide range of maintenance and repair activities on production equipment, lab equipment, and building management systems.
• Provide guidance and leadership to team members.
• Assist in troubleshooting and repair of process equipment (e.g., containment isolator systems, filling line equipment and utilities) with minimal supervision.
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications for planning and performing maintenance and repairs.
• Support 24x7 site-based operations after startup.
• Write/revise accurate operational procedures, training documents, and maintenance procedures for various production and utility systems.
• Provide radiation safety program support, responsible for calibration and functionality of radiation detection equipment.
• Complete equipment work orders thoroughly and accurately and document them in the system.
• Supply information and technical data for securing spare parts.
• Provide responsive customer support with emphasis on customer satisfaction.
• Perform startup and commissioning activities as required.
• Support and/or perform investigations/deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs.
• Perform preventative and corrective maintenance on manufacturing process equipment within a cleanroom environment.
• Complete and provide accurate documentation as required in cGMP operations.
• Oversee work and provide training to less experienced maintenance technicians and/or new technicians.
• Other related duties as assigned.
• Use CMMS system for documentation of relevant work.

Qualifications

• High School diploma or equivalent required; Bachelor's Degree preferred.
• 5+ years of relevant hands-on plant maintenance experience in a regulated GMP environment required.
• Previous supervisory, team/project lead experience required.
• Previous aseptic fill/finish and/or radiopharmacy experience preferred.
• Previous pharmaceutical or medical device experience preferred.
• Completed training in radioactive or hazardous materials environment preferred.
• Ability to adhere to all applicable procedures, policies, and quality/regulatory requirements (e.g., OSHA, DEA, FDA, EMEA, ANVISA, HS&E).
• Experience working in a team environment with strong communication and organizational skills.
• Proficient with MS Office, Building Management Systems, and CMMS or similar systems.
• Ability to climb ladders and lift up to 50 lbs.
• Wearing protective clothing, including respiratory protection, confined space entry, and clean room environments.
• Must be flexible to work nights, weekends, and holidays as required.

Skills

• Maintenance planning and troubleshooting
• Leadership and training abilities
• Reading and interpreting P&IDs, layouts, and schematics
• Radiation safety program knowledge
• Documentation and record-keeping (cGMP/CMMS)
• Communication and teamwork

Education

• High School diploma or equivalent required; Bachelor's Degree preferred.

Additional Requirements

• Requires the ability to work in a regulated environment with potential exposure to hazardous materials and radiation; may require shift flexibility and on-call support as needed.