摘要
The Process Engineer is responsible for identifying, designing and implementing continuous improvement initiatives using advanced engineering principles in a GMP environment to ensure the delivery of high-quality radioligand therapy (RLT) products. Responsible for reliable, efficient and sustained operation of the facility and all production equipment. Additionally supports current project operations and site goal objectives and ensures compliance with regulatory, corporate, and site requirements related to Engineering.
About the Role
Major accountabilities:
- Provide technical troubleshooting throughout equipment lifecycle (startup, qualification, commercial production)
- Perform investigations / deviations from an engineering perspective to allow for timely closure of deviations and CAPAs
- Lead or contribute to process equipment and utility improvement projects
- Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed
- Write/revise engineering documents for operation of various production systems
- Ensure compliance with industrial standards and GMP guidelines
- Develop project cost estimation and value improvement review
- Perform GMP risk assessments
- Manage technical / engineering changes through site change control process
- Participate in preparation of calibration/maintenance risk assessments for new equipment
- Create/execute Design Qualification (DQ), Installation and Operational Qualification (IOQ), and Performance Qualification (PQ) protocols
- Support internal and external audits
The salary for this position is expected to range between $63,600 and $118,200 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.
Minimum Requirements:
- B.S. degree in Chemical, Electrical, Mechanical or Nuclear Engineering, or related technical field, with a 1+ years experience providing automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry
- Proven skills in project management and problem solving
- Exceptional time management, planning, organizational, negotiating and influencing skills
- Highly self-motivated with a willingness to assume responsibilities and take ownership for work
- Must be able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, FDA, EMEA, HS&E, etc.)
- Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS) and similar GMP systems
- Ability to climb ladders and lift up to up to 50 lbs.
- Aseptic Filling line, packaging operation experience is preferred
- Training/experience in radiochemistry or radio safety is desirable
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? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & 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 to perform the essential functions of a position, please send an e-mail to [email protected] or 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.
