May 06, 2022

Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently!

Novartis is seeking a Sr. Manufacturing Technical MES Systems Technician to join the team at our Morris Plains, NJ location. This position will be 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 AQWA.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.

Primary Responsibilities:
Design, implement, and test MES based on the Business process flow.
• Provide MES 24/7 support for production.
• Implement and maintain LIMS interactions and calculations, AQWA for
deviation generation during the process, and interface with SAP system
to issue materials to MBRs that are acceptable & released.
• Support the development and optimization of manufacturing processes.
• Configure/update MES to support change requests.
• Communicate with MES Global Novartis Team to ensure that local MES is
aligned with the Global format and structure.
• Properly control the release of proprietary documentation.
• Coordinate the review and revisions of procedures, R&D documentation
and FDA regulations for inclusion in Production instructions and
quality control manuals.
• 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.
• Coordinate with IT group MES upgrades and/or changes to the system
for Compliance, Training, MBR changes, and User ID controls.
• 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: set up of Status
Diagrams for objects in MES and paperless production recipes within the
MES system.
• Support the creation and update process of documentation in regards
to MBR design and approval, EBR execution and release.
• Support the creation and update of MES Business Process
• Support the MES Operational Qualification (OQ) and Performance
Qualification (PQ) for the End-to-End MBR execution.
• Coaching & training of MBR and EBR execution process for MES Subject
Matter Experts, MBR Designers, and key users.

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you will bring to the role:
• Bachelor’s degree or equivalent work experience
• 5+ years of experience in a regulated cGMP environment, preferred.
• 2 - 5 years Manufacturing Execution Systems primarily in having
designed and created best practice MBRs, preferred.

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

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.

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].

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/network
Novartis Technical Operations
Morris Plains, NJ
Technical Operations
Full Time
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Sr. Manufacturing Technical MES Systems Specialist

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