Aseptic Process Expert

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! The Aseptic Process Expert provides direct front line support to production activities using technical understanding and knowledge of cGMPS, SOPs, and process steps with a focus on aseptic technique and sterility assurance. Accountable to support process issues, protocol generation, general documentation support, deviation investigations, and continuous improvement of the process that are related to sterility, environmental monitoring, and aseptic practices.Your responsibilities include, but are not limited to:• Support a culture of safety, quality, diversity, and inclusion.• Provide front line support to manufacturing shifts to ensure safe, quality, and timely completion of product batches in an aseptic manner and assuring sterility of the product.• Manage and maintain manufacturing documentation including Aseptic Process Simulation protocols (Media Fills), sterility risk assessments, Contamination Containment Strategy, and other associated documents.• Own or support EM data gathering, trending, and alert levels. Analyze and write reports with conclusions and recommendations based to the Site Lead team based on data.• Advise the Site Lead Team on the Sterility program, champion and own any recommendations for improvement of the Contamination Containment Strategy.• Act as site Subject Matter Expert for Media Challenges, Bioburden studies, Smoke Studies, Disinfectant testing, Aseptic Manipulations, aseptic behaviors and management, and Gown Training.• Actively leads and supports investigations into process/product issues in support of sterility, media fill, environmental monitoring excursions and EMPQ and assists with establishing root cause and CAPA.• Supports regulatory audits as Aseptic Sterility Assurance subject matter expert. • Manage the Aseptic Training Program and provide training to aseptic operators.Additional Specifications • This position will involve wearing protective clothing and working in a Manufacturing Grade C clean room environment.• Strong interpersonal, written, communication skills along with problem solving and follow-up skills.• Well organized, flexible, and work with minimal supervision.The pay range for this position at commencement of employment is expected to be between $97,600.00 and $146,400.00 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.https://www.youtube.com/watch?v=ggbnzRY9z8w

Salary : $97,600 - $146,400