Address
Form of workAbout the role
Location: On-site
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 (RLT) to cancer patients.
The Manufacturing Engineer will execute engineering activities (automation, qualification, maintenance, projects, etc.) Leads small semi-complex projects and compliance initiatives. Engineer will work effectively in multiple engineering subject areas.
• Assist with preparation of plans for maintenance / calibration / qualifications.
• Handle technical / engineering changes: originate Change Request, approve Change Request, close Change Request.
• Assist with preparation of estimates for bids and proposals and create/Execute DQ, IQ and OQ protocols and reports and perform GMP risk assessments (incl. Sensors SRA).
• Independently manage and resolve deviations on equipment and systems and provide technical trouble shooting during Startup, PQ and validation activities.
• Develop and execute periodic requalification plan.
• 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.
• Write/revise accurate engineering documents for various production system and supply information and technical data for securing spare parts.
• Cross train on multiple engineering areas (Automation, Qualification, Project, etc.) to gain a greater breath of overall department responsibilities.
• Work collaboratively within multi-functional teams and across various departments such as MS&T, QC, QA, Project Management, and Production.
• Be responsible for the Training Curriculum for own Job Profile.
• Support and/or lead general or semi-complex equipment, utility, facility improvement projects.
• Trains engineering specialists, operators and/or technicians.
• Able to work collaboratively.
• Perform troubleshooting and root cause analysis to develop robust CAPA plans for site issues.
• Prepare and execute IQ, OQ and PQ protocols, and generate associated reports.
• Assist with the management of the automation systems at the site including building management systems (BMS), environmental monitoring systems (EMS), process and laboratory automation.
• Support automation qualification activities.
• Lead / perform / plan and ensure manufacturing / major laboratory equipment preventive maintenance and calibration according to plan. Monitor work order status, follow up to close open work orders in timely manner into the maintenance tracking software system.
• Training personnel on equipment operating and maintenance procedures as applicable.
• Provide radiation safety program support, responsible for calibration and functionality of all radiation detection equipment.
• 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.).
Role Requirements
• B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 3+ years' experience providing maintenance, automation, engineering, or similar support within the pharmaceutical, biotechnology, or related industry OR Associates Degree/Diploma/Certification in Engineering Technology or Related Skilled Technical Field, with 5+ years' work experience providing maintenance, automation, engineering, or similar support within the pharmaceutical, biotechnology, or related industry.
• Ability to effectively present semi-complex ideas and solutions
• Basic knowledge of CAD system or similar system
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the -most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
Learn more here: https://www.novartis.com/about/strategy/people-and-culture
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.
You'll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/en_US/network.
EEO Statement
We are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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 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: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Location: On-site
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 (RLT) to cancer patients.
The Manufacturing Engineer will execute engineering activities (automation, qualification, maintenance, projects, etc.) Leads small semi-complex projects and compliance initiatives. Engineer will work effectively in multiple engineering subject areas.
• Assist with preparation of plans for maintenance / calibration / qualifications.
• Handle technical / engineering changes: originate Change Request, approve Change Request, close Change Request.
• Assist with preparation of estimates for bids and proposals and create/Execute DQ, IQ and OQ protocols and reports and perform GMP risk assessments (incl. Sensors SRA).
• Independently manage and resolve deviations on equipment and systems and provide technical trouble shooting during Startup, PQ and validation activities.
• Develop and execute periodic requalification plan.
• 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.
• Write/revise accurate engineering documents for various production system and supply information and technical data for securing spare parts.
• Cross train on multiple engineering areas (Automation, Qualification, Project, etc.) to gain a greater breath of overall department responsibilities.
• Work collaboratively within multi-functional teams and across various departments such as MS&T, QC, QA, Project Management, and Production.
• Be responsible for the Training Curriculum for own Job Profile.
• Support and/or lead general or semi-complex equipment, utility, facility improvement projects.
• Trains engineering specialists, operators and/or technicians.
• Able to work collaboratively.
• Perform troubleshooting and root cause analysis to develop robust CAPA plans for site issues.
• Prepare and execute IQ, OQ and PQ protocols, and generate associated reports.
• Assist with the management of the automation systems at the site including building management systems (BMS), environmental monitoring systems (EMS), process and laboratory automation.
• Support automation qualification activities.
• Lead / perform / plan and ensure manufacturing / major laboratory equipment preventive maintenance and calibration according to plan. Monitor work order status, follow up to close open work orders in timely manner into the maintenance tracking software system.
• Training personnel on equipment operating and maintenance procedures as applicable.
• Provide radiation safety program support, responsible for calibration and functionality of all radiation detection equipment.
• 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.).
Role Requirements
• B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 3+ years' experience providing maintenance, automation, engineering, or similar support within the pharmaceutical, biotechnology, or related industry OR Associates Degree/Diploma/Certification in Engineering Technology or Related Skilled Technical Field, with 5+ years' work experience providing maintenance, automation, engineering, or similar support within the pharmaceutical, biotechnology, or related industry.
• Ability to effectively present semi-complex ideas and solutions
• Basic knowledge of CAD system or similar system
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the -most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
Learn more here: https://www.novartis.com/about/strategy/people-and-culture
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.
You'll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/en_US/network.
EEO Statement
We are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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 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: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
- Novartis: e-mail us.reasonableaccommodations@novartis.com or call +1 (877)395-2339
- Sandoz: e-mail reasonable.accommodations@sandoz.com or call: +1-609-422-4098
