The Maintenance & Calibration Supervisor is responsible for performing leading a team responsible for corrective and preventative maintenance and support services for the building(s) and all equipment for a GMP Radioligand Therapies Production Facility. Responsible ensure execution of 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.
• Supervises cGXP Metrology Maintenance services including planning and maintenance of equipment which may include one or more of the following:
• Assist in advanced troubleshooting and repair of utility systems which may include HVAC, Cold/Warm Rooms, control systems, compressed gases, plant steam/condensate, filling line.
• Manage work requests/work orders, including processing, generation, tracking and follow-up; ensure work order completion, review, approval, and close-out.
• Manage calibration program schedule and preventative maintenance; ensure on-time completion and review BMRAM work orders for accuracy and GMP compliance
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs.
• Support 24×7 site-based operations after startup.
• Identifies opportunities to eliminate waste within the metrology space. For example, identifying equipment that should be decommissioned, reduce frequencies of calibrations/pms based on historical data, etc
• Write/revise accurate operational procedures, training documents and maintenance procedures for various production and utility systems.
• On a daily basis, activity works on open work order, completes Equipment Work Order Thoroughly, and Accurately and Documents them in the System
• Provide radiation safety program support, responsible for calibration and functionality of all radiation detection equipment
• Develop and report maintenance / metrics. (KPI’s)
• Supply information and technical data for securing spare parts.
• Provide responsive customer support with emphasis on customer satisfaction.
• Support internal and external auditing activities
• 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.
• Assist in development of monthly finite schedule for GMP clean room maintenance activities
• Oversee work and provide training of less experienced maintenance technicians and/or new technicians.
• Utilize and administrate CMMS system for documentation of relevant work.
The pay range for this position at commencement of employment is expected to be between $92,800 and $139,200 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.• High School diploma, technical degree, or equivalent and 3+ years of experience hands-on plant maintenance experience in a regulated facility
• 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.
• Experience working in a team environment, with excellent communication and organizational skills
• Good documentation and record keeping skills and attention to detail
• Ability to focus on a variety of issues and drive to results
• 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.
• Must be flexible to work nights, weekends, and holidays as required
• Previous experience in pharmaceutical based GMP manufacturing operations including aseptic fill/finish and/or radio pharmacy is preferred
• 1+ year in managing a team (exempt, non-exempt, or contractors) in regulated environment is preferred
• Training in radiochemistry or radio pharmacy is preferred
• Radiation safety education is preferred
Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
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