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该岗位为诺华GMP放射配体疗法生产设施的维护技术员,主要负责建筑物及设备的纠正性和预防性维护工作。支持24x7现场运营,需在洁净室环境中进行制造设备的维护与故障排除,并参与辐射安全项目支持。
Band
Level 1
Job Description Summary
The Maintenance Technician is responsible for performing corrective and preventative maintenance and support services for the building(s) and all equipment for a GMP Radioligand Therapies Production Facility. 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.
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.
• 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 $47,500 and $88,300 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.
Minimum Requirements:
• High School diploma or equivalent is required; Bachelor's Degree is preferred.
• 1+ years of relevant hands-on plant maintenance experience in a regulated GMP environment is required.
• 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.
• 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.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 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 tas.nacomms@novartis.com 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.
https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings
Salary Range
$47,500.00 - $88,300.00
Skills Desired
Control Systems, Engineering Technical Expertise, GDP Knowledge, gmp knowledge, HSE Knowledge, Knowledge Of Relevant Tools And Systems, Manufacturing Process (Production), Operational Excellence, Total Productive Maintenance批发业
负责生产线质量控制与检验,涵盖包装材料、空瓶、灌装及标签过程的质量验证。执行GMP、HACCP、FSSC 22000等食品安全标准,识别并控制不合格产品,维护质量记录并支持持续改进。要求食品技术、化学