About the role:
Responsible for the design, implementation, and verification of electronic Master Batch Records (MBRs) and provide oversight and execution for the Manufacturing Execution System (MES) which will automate much of the record keeping, information flow and documentation for Morris Plains Cell Processing Operations. This includes paperless manufacturing instructions, paperless in process control, enforcing process sequencing and electronic go/no go decisions, process validation ranges, formulas to ensure the final yield is within acceptable percentages, and interface with the various systems in place including SAP, LIMS, and 1QEM. This role requires strong collaboration with the GMP Documentation Coordinator role within Operations to ensure priorities are being addressed in a timely manner to meet CTL019 and other Product Launch timelines.
Your Key Responsibilities:
•Design, implement, and test MES based on the Business process flow.
•Provide MES 24/7 support for production for troubleshooting purposes
•Implement and maintain LIMS interactions, 1QEM for deviation generation during the process, interface with SAP system to issued materials to MBRs and other potential future systems that are interfaced with MES. Ensure they are acceptable & released as required.
•Support the development and optimization of manufacturing processes.
•Configure/update MES to support change requests
•Own and Support Change Controls related to MES
updates
•Own CAPAs related to MES updates
•Represent MES in local/global SPOC and CCRB
meetings
•Provide departmental evaluations for changes
controls
•Ensure all MES MBR revisions are aligned with
timelines to meet required CR updates
•Coordinate with IT group MES upgrades and/or changes to the system for Compliance, Training, MBR changes, and User ID controls and support any system qualification needs.
•Liaise with Subject Matter Experts, Process Experts, Validation, QA and Compliance during the MBR design, creation and verification process.
•Support Local Master Data configuration in MES and the creation and update of MES Business Process mapping/configuration.
•Support the creation and update process of documentation in regards to MBR design and approval, EBR execution and release.
Commitment to Diversity & Inclusion:
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:
Role Requirements
Role Requirements:
•Bachelor’s degree preferred or equivalent experience
•5 years of experience in a regulated cGMP environment, preferred.
•At least 2 years of Manufacturing Execution Systems primarily in having designed and created best practice MBRs
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
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
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
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.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $112,800 and $169,200; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. 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.
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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