As a Process Expert you will provide direct, front-line support to manufacturing using your technical understanding and knowledge of cGMPs, SOPs, and industry best practice. You will be accountable for addressing process issues, protocol generation, documentation, deviation investigations, and continuous process improvement while fostering a culture of safety, quality, diversity, and inclusion.
Key Responsibilities:
• Act as Subject Matter Expert (SME) for product and process knowledge and provide input to the Annual Product Review. Ensure processes are always inspection ready.
• Manage and maintain documentation including Master Batch Records, SOPs, risk assessments, protocols, etc. Support validation protocol generation and execution.
• Track and trend critical process parameters and in-process checks. Lead ongoing process verification (OPV).
• Investigate deviations and determine root causes and identify CAPAs. Identify, assess, and own technical changes through GMP change control processes.
• Provide guidance and support to production team through training and knowledge sharing.
• This position will involve wearing protective clothing and working in a Manufacturing Grade C clean room environment.
• This position requires shift work including weekends and off hours support.
Minimum requirements
Essential requirements:
•Bachelor’s degree in a STEM field (preferred) or equivalent experience.
•3+ years of experience in a GMP environment or relevant regulated industry
•1+ year of experience in a process support floor role in manufacturing
•Knowledge of Continuous Improvement Methodology
•Strong interpersonal and written communication skills
•Demonstrated problem solving skills.
•Well organized, flexible, and work with minimal supervision.
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 $80,000.00 and $120,000.00 per year; 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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
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