Senior Process Engineer, Multidiscipline
Novartis
United States
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Summary
The Senior Process Engineer, Multidiscipline is responsible for support in execution of engineering processes/activities within an aseptic environment (design, implementation, maintenance, etc.) by providing a technical area of expertise while using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives in accordance with the law, internal regulations. 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
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 professionals to help us reach our ambitious goals.
Location: Onsite
Major Accountabilities
Minimum Requirements
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.
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
The Senior Process Engineer, Multidiscipline is responsible for support in execution of engineering processes/activities within an aseptic environment (design, implementation, maintenance, etc.) by providing a technical area of expertise while using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives in accordance with the law, internal regulations. 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
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 professionals to help us reach our ambitious goals.
Location: Onsite
Major Accountabilities
- Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI).
- Assist with preparation of plans for maintenance / calibration / qualifications.
- Provides hands-on support and guidance of installation, maintenance, troubleshooting, and repair of assets and systems which support the manufacturing facility.
- Creates, reviews, and approves critical documentation such as operational procedures, maintenance plans, engineering drawings, and equipment specifications.
- Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request.
- Assist with preparation of estimates for bids and proposals.
- Perform GMP risk assessments (incl. Sensors SRA).
- Independently leads and/or provide SME-level support on all phases of projects, from identification to close out.
- Ensures new equipment is appropriately designed/commissioned/qualified and existing processes run in a compliant manner throughout the equipment lifecycle.
- Support internal and external audits.
- Use automation (Scada / PLC's / Control Networks hardware) for data gathering and equipment optimization opportunities
- Assist in troubleshooting of process / plant equipment including isolator, filling line and utilities.
- Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed.
- Supply information and technical data for securing spare parts.
- Provide responsive customer support with emphasis on customer satisfaction.
- Perform startup and commissioning & qualification 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
- Leads small teams to advance facility and equipment changes in line with 5- and 10-year strategic plans.
- Complete and provide accurate documentation, as required in cGMP operations.
- Actively monitors equipment performance in compliance with site reliability and maintenance strategies.
- Collaborates with operations and manufacturing sciences to evaluate new product introductions and facility fit evaluations.
- Other related duties as assigned.
- Use of CMMS system for documentation of relevant work.
Minimum Requirements
- B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 8+ years’ experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry
- OR Associates Degree/Diploma/Certification in Engineering Technology or Related Skilled Technical Field, with 10+ years’ work experience providing maintenance, automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry.
- Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
- Excels in a team environment, with excellent communication and organizational skills. Promotes information sharing, facilitates groups to ensure open discussion.
- Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results.
- Strong project management skill set with ability to manage projects from start-to-end.
- Applied knowledge of root cause analysis, equipment troubleshooting, automated building management systems, and industrial PLCs
- 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.)
- Proficient computer skills. Experience using a Computerized Maintenance Management System (CMMS) like Blue Mountain Ram or SAP
- Ability to climb ladders and lift up to 50 lbs.
- Aseptic Filling line, packaging operation experience is preferred.
- Training in radiochemistry or radio pharmacy is preferred.
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.
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Management and Manufacturing -
Industries
Pharmaceutical Manufacturing
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