Process Expert job opportunity at Novartis.

Home Jobs In United States Of America Tag: Job Process Expert position at Novartis


DateMore Than 30 Days Ago bot
Novartis Process Expert
Experience: 3-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeAssociate
loacation Morris Plains, United States Of America
loacation Morris Plains....United States Of America

Job Description Summary The Process Expert will provide front line support for all issues related to the manufacturing process, continuously improving in quality and efficiency, and in compliance to cGMPs, SOPs and applicable guidelines and normatives.   Job Description 365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives. This role is located on-site in Morris Plains, NJ. Novartis is unable to offer relocation support for this role.  Please note this is a 1st shift role. The shift will be Sunday through Wednesday OR Wednesday through Saturday. Major accountabilities: Shop Floor Support: Provide front line technical and procedural support to manufacturing, working with the cell processing team, focusing on manufacturing each batch safely, on time, in compliance with the batch record and quality requirements. Provides latest information regarding best practices, investigation findings, CAPAs, MST/TRD experiences to manufacturing SMEs. Perform data analysis and identifies potential process shifts/trends and escalate as necessary. Deviations, Investigations, and CAPAs: Author investigations for product and non-product deviations. Conduct manufacturing investigations for Out Of Expectation (OOE), Out Of Specification (OOS), Out of Tolerance (OOT) results. Work cross-functionally to assess deviation impact and identify root causes. Work with Scheduling and QA to ensure that batches of are released on time through the closure of robust investigations and impact/risk assessments. Use process knowledge and root cause investigation tools to analyze data and to identify and root causes of product and process failures. Initiate CAPAs and CAPA effectiveness checks to eliminate/mitigate deviations. Support the process of escalation of deviations when appropriate according to escalation guidelines. Present escalation events and provide deviations details clearly and on-time (root cause and CAPAs). Business Process & Improvements: Identifies opportunities for process, operational, and quality improvements in conjunction with Manufacturing Team (PU) and Operational Excellence Team (OpEx). Execute process technical batches to generate sufficient process knowledge by thoroughly testing critical variables. Evaluates manufacturing pre-production technical planning, review of technical data of incoming apheresis materials, to ensure timely and required batch pathway processing by the manufacturing team. Provide timely updates to management on status of manufacturing performance. Escalate potential performance issues to 3rd parties. Technology Transfer: Provide timely support for process technology transfer activities from clients/3rd parties. Training: Develop and provide training (as immediate response to unexpected events, for technical document execution, and new products/processes) to the Cell Processing team, as required. Owns the Training Curriculum for this Job Profile and provides the necessary training and support to new associates joining the Process Expert position. Coach new investigators as part of the Investigator Certification Program. Audit Support: Maintain their processes at inspection readiness level and to provide the necessary support in any internal or external audit. Authorities' inspections The salary for this position is expected to range between $77,000 and $143,000 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, Engineering or Biology or related field is required 3+ years of relevant experience in pharmaceutical industry is required. Previous GxP experience is required. Excellent communication and collaboration skills.   EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.    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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.   Salary Range $77,000.00 - $143,000.00   Skills Desired Change Control, Chemical Engineering, Continual Improvement Process, Efficiency, Employment Discrimination, Flexibility, General Hse Knowledge, Good Documentation Practice, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Physics, Process Control, Production Line, Productivity, Risk Management, Root Cause Analysis (RCA), Scheduler, Technology Transfer, Well-Being

Other Ai Matches

Tehnolog proizvodnega inženiringa (m/ž/d) / Engineer Multidiscipline II (m/f/d) Applicants are expected to have a solid experience in handling Job related tasks
Facility Coordinator with French Applicants are expected to have a solid experience in handling Job related tasks
Laboratory Systems Technical Specialist Applicants are expected to have a solid experience in handling Job related tasks
Senior Specialist Data Science & AI - Big Data Engineer Applicants are expected to have a solid experience in handling Job related tasks
PRODUCT MANAGER (H/F) en alternance Applicants are expected to have a solid experience in handling Job related tasks
Material Coordinator Applicants are expected to have a solid experience in handling Job related tasks
Sr. Procurement AI & Analytics Lead Applicants are expected to have a solid experience in handling Job related tasks
Medical Science Liaison (MSL) Cardiometabolic South Texas Remote Applicants are expected to have a solid experience in handling Job related tasks
Value & Access Head Applicants are expected to have a solid experience in handling Job related tasks
Vodja varstva osebnih podatkov ter skladnosti na področju digitalizacije in umetne inteligence (m/ž/d) / Head of Data Privacy, Digital and AI Compliance (m/f/d) Applicants are expected to have a solid experience in handling Digital and AI Compliance (m/f/d) related tasks
HSE Technician (Isotopes) Applicants are expected to have a solid experience in handling Job related tasks
Vendor Alliance Lead Associate Director (Cardiac Safety and Diagnostics) Applicants are expected to have a solid experience in handling Job related tasks
Snr. Specialist, ITOT Business Services / Solutions Delivery Applicants are expected to have a solid experience in handling ITOT Business Services / Solutions Delivery related tasks
Business Workstream Lead LDC (Lean Digital Core) / GMT Applicants are expected to have a solid experience in handling Job related tasks
In-Market Brands Manager Applicants are expected to have a solid experience in handling Job related tasks
remote-jobserver Remote
Neuroscience Area Business Leader – Boston, MA Applicants are expected to have a solid experience in handling MA related tasks
Manager, AI Innovation Lab (Learning and Training Assets Delivery) Applicants are expected to have a solid experience in handling AI Innovation Lab (Learning and Training Assets Delivery) related tasks
Maintenance Technician (Electrical) (m/w/d) - Schaftenau, Tirol Applicants are expected to have a solid experience in handling Tirol related tasks
Vodja upravljanja kakovosti - operacije (m/ž/d) / QA Operations Lead (m/f/d) Applicants are expected to have a solid experience in handling Job related tasks
Snr. Specialist, Platform Services - Data, Digital & IT Applicants are expected to have a solid experience in handling Platform Services - Data, Digital & IT related tasks
Country Promotion Manager | Immunology Applicants are expected to have a solid experience in handling Job related tasks
Senior Analyst - Brand Analytics Applicants are expected to have a solid experience in handling Job related tasks
Executive Director, Human Insights and Analytics Applicants are expected to have a solid experience in handling Human Insights and Analytics related tasks