Swiftwater, PA, 18370, USA
2 days ago
Manager Senior Packaging Engineer
**Job title** : Manager Senior Packaging Engineer **Location:** Swiftwater, PA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The role of the Manager Sr. Packaging Engineer involves identifying, and resolving compliance, and efficiency issues that impact the Secondary Packaging Operations in Swiftwater, PA. This position actively contributes as a member of cross-functional teams, serving as an interface between the FFIP platform, maintenance, engineering and the Technical Community. The Sr. Packaging Engineer is responsible for all activities related to the Continuous Improvement of Packaging for Drug Products and process monitor program. As an individual contributor within the organization, the role encompasses membership in cross-functional teams supporting continuous improvement for packaging with a focus on Secondary Packaging operations. Additionally, the Sr. Packaging Engineer provides project support for cross-functional teams, serving as the area interface for addressing Packaging processes, operations and project-related issues. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. **Main Responsibilities:** + Provides technical supports to Engineering, Maintenance, Quality Supplier, Quality Assurance (QA), and Quality Validation (QV) + Working knowledge of packaging materials specifications, Serialization, packaging formats/ID’s creation, packaging equipment and component troubleshooting. + Responsible for the Process Monitor program for the Packaging department, that includes tracking of reconciliation data, initiates excursion reports as needed and presents data to the team monthly. + Responsible to train/mentor new and existing engineers, managers and maintenance personnel on packaging programs that include formats/ID’s creation, troubleshooting and packaging sterilization, etc., + Provide support to shopfloor managers on packaging component, equipment and operations. + The ability to work independently or with other group to identify packaging issues, formulate solutions and implement changes as needed. + Utilizing the "+QDCI" Visual Management Systems and working with the FFIP Management Committee to drive improvements in key metrics. + Ensure compliance with all regulatory requirements and good documentation are followed to provide a safe, quality, and effective finished product. + This position will support both the needs of packaging, process monitor as well as project related activities. + The position will also require evaluation of packaging operation performance and finding ways to improve OEE and reduce equipment downtime. + Having a strong working knowledge of the relationship between packaging component, and equipment characteristics and all critical quality attributes. + Coordinate project validation approach with Packaging Personnel, Engineering, Maintenance and Site Quality Operations. + Strong customer communication and the ability to work with multiple groups to complete projects for new and existing packaging formats within the FFIP. + This position will have interactions with Health, Safety and Environment (HSE), Engineering, Site Quality Operations, Information Technology & Solutions, Outside Contractors/Consultants, Vendors, Industrial Operations and Research & Development departments. + Leading tactical responses to equipment/component/process monitor related excursion, Agency observations, delivering technical solutions and communicating outcomes to site management. + Review/approve process design specifications, technical documents, validation project plans and assist on the execution of equipment/component validation. + Author / review / execute/ approve technical documents which support equipment/component testing. + Author Change Control which supports equipment/component related changes and project works. + Promote innovation to keep up to date with the latest regulatory expectations, Technology, and industry standards. **About You** **Basic Qualifications:** + B.S. in electrical, mechanical and/or other applicable engineering field required. + 2-5 years of experiences in pharmaceutical, biotech, food, medical Device in manufacturing, maintenance, and engineering or other industries will be considered. + At least 1-year experiences working with packaging equipment/component in a pharmaceutical cGMP or food industry environment or other industries will be considered. + Functional experience with packaging equipment/component and process monitor. + Understanding of Code of Federal Regulation (21 CFR Part 210 & 211) guidance regarding Packaging Operations. + Requires 100% on-site present during normal workdays and willing to provide support during the off-shit hours occasionally that include remote or on-site. + Experience in customer support, operational excellence, and troubleshooting. **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. 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. \#GD-SP ​ \#LI-SP \#LI Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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. Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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