About the Role
Major Accountabilities:
- Responsible for the manufacturing documentation update following the implementation of electronic batch files
- Provide training for MES users in partnership with the training team
- Ensure follow-up and processing of deviations and Change Control in compliance with deadlines and applicable regulations
- Real time shop floor troubleshooting with the implementation of appropriate immediate corrective actions
Expertise / Compliance
- Subject matter expert for MES / SAP / Historian type of production IT systems
- Support deviation and complaint investigations process using investigation tools and methodology
- Develop on-site expertise (MBR design, PAS-X, OSI-PI, interface with SAP and Trackwise)
- Master PAS X and OSI PI systems
- SPOC for major trouble shooting, CAPA execution, change controls management and follow-up for production IT systems
- Prepare, support and follow-up of Health authority and internal inspections
Continuous improvement
- Continually seek to improve the efficiency of its work and simplify processes
- Contribute to continuous improvement by making proposals and participating in the implementation of tangible and effective actions.
The salary for this position is expected to range between $81,200 and $150,800 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Minimum Requirements:
- Bachelor's Degree in Science, Pharmacy, Chemical Engineering or Pharmaceutical Technology or equivalent job experience.
- 5+ years of relevant experience in GMP manufacturing process support role.
- Proven experience in MES expert role
Role Requirements
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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