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Manufacturing Technical MES System Specialist

  • Batch Record
  • CGMP
  • Documentation
  • ERP
  • Maintenance
  • MS Office
  • Proofreading
  • SAP
Description:

~~This is a temporary contractor opportunity at Novartis ~~
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life! 
  
Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com 
  
Ready to work with/through Magnit at Novartis? Please read on... 
Manufacturing Technical MES System Specialist
Job Description:

Responsible for maintaining and updating current established electronic batch records in the PAS-X Werum MES (manufacturing execution system) for the Cell & Gene site in Morris Plains. Personnel must be skilled in Master Batch Record creation and maintenance for MES Production system. Create new electronic batch records as required to support production processing.
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. MES is interfaced with SAP System to issue Materials to MBRs that are acceptable & released.

Major Accountabilities:
• Provide paperless Production recipes within the MES PAS-X system.
• Maintain, create and support PU process improvement changes.
• Provide MES support for Production on processing troubleshooting issues
• All maintenance activities for Master Batch Records, following all appropriate procedural documentation.
• Implementation and maintenance of LIMS interactions and interactions for deviation generation during the process.
• Provide timely and error free documentation.
• Properly control the release of proprietary documentation.
• Demonstrate technical knowledge in MES systems.
• Reduce the number of Master Batch Record revisions due to record flow or design
• 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.
• Work with Manufacturing Team to implement change improvements
• Maintain Material Master within the SAP System
• Backup to SAP Bill of Material Maintenance.
• Coordinate with IT Group MES upgrades and or changes to the system for Compliance, Training & MBR changes.
• Coordinate with IT group User ID controls.

Education
Bachelor or similar degree

Languages: 
Fluent in English.
Experience / Professional Requirements: 
3+ years experience in a regulated cGMP environment or other regulatory related industry preferred Pharma Industry
3+ years Manufacturing Execution Systems required
Strong aseptic manufacturing knowledge background preferred.

Competency Profile
This professional must be proactive, responsive, and able to work independently with all levels of the organization. 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. Capability to handle multiple conflicting tasks in a fast-paced environment is a must. Very high attention to detail is critical, including strong writing and proofreading skills. Skilled in Master Batch Record Creation and Maintenance for both Production using MES (Manufacturing Execution Systems).

Location: Morris Plains, NJ (Onsite) 
Pay Rate: $45 - $65/hour
Contract: 6 - 12 months 
Health, dental, vision, 401k

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 we can reinvent what's possible when we collaborate with courage to ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! 
Imagine the impact you could make here at Novartis! 
  
Commitment to Diversity & Inclusion: 
Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve. 
To do our best work we need different viewpoints, which is why here at Magnit, we celebrate diversity and embrace inclusion. As an equal opportunity employer, Magnit is dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all. 
  
Accommodation: 
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com or 1.862.778.5441. 

QUALIFICATION/ LICENSURE :
  • Work Authorization : Green Card, US Citizen, Other valid work visa
  • Preferred years of experience : 3+ Years
  • Travel Required : No travel required
  • Shift timings: Onsite: Morris Plains, NJ
Job Location
Morris Plains, New Jersey
Pay
USD 45.00 - USD 65.00 Per Hour
CONTRACT DURATION
6 month(s)
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