Manager APM - EM-Swiftwater, PA
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.
Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic
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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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