Manager APM - EM-Swiftwater, PA
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Swiftwater, PA-This position will represent Aseptic Performance Monitoring by coordinating and/or attending routine meetings, spending time on the shop floor, writing reports and providing guidance and assistance to the site as related to Environmental Monitoring programs and practices.
* This position will support the Environmental Monitoring group within the Aseptic Performance and Monitoring (APM) organization.
*The individual will be responsible for programs and processes within the Environmental Monitoring group in support of the assigned area (Antigen and/or FFIP factories) along with project support for Environmental Monitoring Performance Qualification (EMPQ) and other APM related execution and monitoring programs.
*This employee will independently author, assess, revise, review and Final approve standard operational documents, reports, protocols, deviation/investigation reports, CAPAs, change control requests, etc. .
*The individual will represent APM with direct Environmental Monitoring knowledge by providing support and serving as SME to internal, corporate, and federal regulatory inspections, by providing pertinent information and material directly to the inspection team.
*The individual will also facilitate system improvements as assigned by APM Deputy Director/Director as well as potentially being called as a subject matter expert when the site is under inspection or audit. Excellent communication skills and the ability to perform training are essential skills needed to be successful in this role. Incumbent will also need a strong customer focus with an ability to prioritize and adapt to the business needs.
*The individual will also provide guidance and support to the process monitoring and APS group within APM as needed.
Key technical competencies and soft skills:
*Must have an understanding of vaccines/biologics products and associated technologies, sterility assurance and associated techniques.
*Must have the ability to aseptically gown.
*Strength in several LEAD Competences-Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions
*Bachelor's Degree in life sciences preferred. Other degree types may be considered with equivalent work experience in life sciences.
*A minimum 5 years’ experience in a cGMP controlled/ pharmaceutical industry.
*3-5 years’ experience/knowledge of: cGMPs and regulatory requirements, contamination control, disinfection, sterility assurance, aseptic processing, and environmental monitoring.
*2-4 years’ experience with computer systems such as TrackWise and Phenix systems GEODE+, BlueCielio, MS Office (Word and Excel).
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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