Team Lead, Engineering Maintenance

Novartis•Indianapolis, IN

1d•Onsite

About The Position

At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Manufacturing professionals to help us reach our ambitious goals. The Team Lead, Engineering Maintenance manages a team of Maintenance technicians to support manufacturing continuously, efficiently, and effectively through maintenance activities (corrective, preventive). Please note that the shift for this role can be 1st or 2nd based on the business need. Location: Onsite Job Description Major accountabilities: Adhere to Novartis Quality Policies and procedures as they pertain to the position to ensure that all products are safe, pure, effective and of the highest quality. Perform a wide range of maintenance 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 (example: containment isolator systems, filling line equipment and associated utility connections) which may include mechanical, electrical wiring, pneumatics, motors, pumps, vacuum systems, HVAC, control systems, compressed gases, filling line, under little to no supervision. Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in 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 all radiation detection equipment Completes Equipment Work Order Thoroughly, and Accurately and Documents 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 related equipment within a cleanroom environment. Complete and provide accurate documentation, as required in cGMP operations. Oversee work and provide training of less experienced maintenance technicians and/or new technicians. Other related duties as assigned. Use of CMMS system for documentation of relevant work. The salary for this position is expected to range between $85,400 and $158,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Requirements

High School diploma or equivalent is required; Bachelor's Degree is preferred.
5+ years of relevant hands-on plant maintenance experience in a regulated GMP environment is required.
Previous supervisory, team/project lead experience is required.
Must be able to adhere to all applicable procedures, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)
Experience working in a team environment, with excellent communication and organizational skills.
Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS) or similar system.
Ability to climb ladders and lift up to 50 lbs.
Wear and work in protective clothing, including respiratory protection, confined space entry and clean room environments.
Must be flexible to work nights, weekends, and holidays as required.

Nice To Haves

Previous aseptic fill/finish and/or radio pharmacy experience is preferred.
Previous pharmaceutical or medical device experience is preferred.
Completed training in radioactive or hazardous materials environment is preferred.

Responsibilities

Adhere to Novartis Quality Policies and procedures as they pertain to the position to ensure that all products are safe, pure, effective and of the highest quality.
Perform a wide range of maintenance 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 (example: containment isolator systems, filling line equipment and associated utility connections) which may include mechanical, electrical wiring, pneumatics, motors, pumps, vacuum systems, HVAC, control systems, compressed gases, filling line, under little to no supervision.
Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in 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 all radiation detection equipment
Completes Equipment Work Order Thoroughly, and Accurately and Documents 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 related equipment within a cleanroom environment.
Complete and provide accurate documentation, as required in cGMP operations.
Oversee work and provide training of less experienced maintenance technicians and/or new technicians.
Other related duties as assigned.
Use of CMMS system for documentation of relevant work.

Benefits

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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