Job Description Summary

The Manufacturing Execution Systems (MES) Specialist will provide oversight and execution for the automated digitalized business processes, information flow and documentation for the production lifecycle. This role supports the maintenance, functionality, and change updates of the MES system to manufacture biopharmaceutical products for the Morris Plains, Cell Processing Operations.

Novartis is unable to offer relocation support for this role. Please only apply if the location is accessible for you.

Job Description

Key Responsibilities:

Skilled in Master Batch Record (MBR) creation and maintenance using MES (Manufacturing Execution Systems).
Update Manufacturing SOPs as required. Own and support Change Control tasks, Quality Events, and CAPAs related to MES updates.
Support all aspects of the MES system - paperless manufacturing instructions, paperless in process control, enforces process sequencing and electronic go/no go decisions, process validation ranges, formulas to ensure the final yield is within acceptable percentages, interface with SAP System to issue materials to Master Batch Records (MBR) that are acceptable & released.
Coordinate the review and revisions of procedures, R&D documentation, and FDA regulations for inclusion in Production instructions and Quality Control manuals.
Communicate with broader MES global team to ensure alignment with the Global format and structure.
Exceptional oral and written communicator who is proactive, responsive, and able to work independently with all levels of the organization. Ability to handle multiple conflicting tasks in a fast-paced environment is a must. Very high attention to detail is critical, including strong technical writing and proofreading skills.
Responsible for ensuring compliance with Federal, State and local regulations and adherence to all company policies and procedures relating to GMP's, Health, Safety & Environmental Protection.

Essential Requirements:

Bachelor's degree required.
Minimum 3 years' experience in a regulated cGMP environment or other regulatory related industry.
1 - 3 years Manufacturing Execution Systems Experience required
Strong aseptic manufacturing knowledge background preferred.
Skilled in Master Batch Record Creation and Maintenance for both Production using MES (Manufacturing Execution Systems).
Must possess full fluency in MS Office (Word, Outlook, PowerPoint, MES, ERP, database management) and be an excellent communicator.
Must be service-minded, flexible, and possess strong interpersonal skills.

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 $84,000 and $126,000 Annual; 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 can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

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

EEO Statement:

The Novartis Group of Companies 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

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

$84,000.00 - $126,000.00

Skills Desired

Change Controls, Chemical Engineering, Continual Improvement Process, Efficiency, Employment Discrimination Law, Flexibility, General Hse Knowledge, Good Documentation Practice, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Processes, Manufacturing Production, Physics, Process Control, Production Lines, Productivity, Risk Management, Root Cause Analysis (RCA), Technology Transfer, Well-Being, Work Schedules