Job Description
Summary 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 Supervisor, Maintenance and Calibration is responsible for oversight and leadership of all maintenance and calibration activities support for the building(s) and all equipment for a GMP Radioligand Therapies Production Facility. They will lead a team of site-based technicians to establish, maintain and improve site maintenance and calibration programs and activities. Responsible for reliable, efficient and sustained operation of the facility and all equipment. Additionally supports current project operations and site goal objectives and ensures compliance with regulatory, corporate, and site requirements related to their functional area.
About the Role Major accountabilities: • Manages team of maintenance and calibrations technicians to support manufacturing continuously, efficiently, and effectively through corrective and preventative maintenance activities.
• Ensures equipment operates to required HSE, Quality, Environmental and Reliability standards
• Contribute to equipment, utility, facility improvement projects (e.g. energy efficiency, productivity, environmental compliance
• Support continuous improvement of the maintenance and calibration program
• Support internal and external audits
• Act as maintenance/calibration SME in relation to new initiatives and special projects
• Enter master data into CMMS (e.g. confirmation and technician time allocations)
• Establish vendor contracts, project engineering & control and identify technical solutions
• Work with maintenance planner to coordinate and plan maintenance / calibration activities
• Perform a wide range of maintenance repair activities on production equipment, central utilities systems, environmental monitoring systems, and building management systems.
• Assist in troubleshooting and repair of various systems (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.
• Write/revise training documents and maintenance procedures for various production and utility systems.
• 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.
• Support startup and commissioning activities with an emphasis on maintenance and calibration development. (Sensor Risk Assessments, Work Plans, FMECA)
• Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs
• Own or support change controls related to maintenance and calibration
• 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 $93,800 and $174,200 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.
Minim um Requirements:
•High School diploma or equivalent is required; Bachelor's Degree is preferred.
• 5+ years of experience in a maintenance or calibration related field
•Previous supervisory, team/project lead experience is required.
• Self-motivated with a strong sense of ownership in areas of responsibility.
• Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
• Demonstrated ability to work and collaborate on cross functional teams (QE, QA, validation, operations) in a fast paced, dynamic team setting.
• Strong interpersonal and excellent verbal and written communication skills are essential.
• Planning, problem analysis, and decision-making skills.
• Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS).
• Must be able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)
• Experience in operating and maintaining mechanical systems in a cGMP or other regulated environment.
• Ability to climb ladders and lift up to 50 lbs.
• Must be flexible to work nights, weekends, and holidays as required.
Desirable requirements: • 3+ years pharmaceutical based GMP manufacturing operations including aseptic fill/finish and/or radio pharmacy (preferred)
• Experience working with/around radioactive material (preferred)
• Radiation safety education (preferred)
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
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Job Tags
Flexible hours, Night shift, Weekend work,