Manufacturing and Supply
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Job Title: Manager, Drug Substance Continuous Improvement – Vaccines (Equipment Qualification)

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.

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:

• Driving projects from conception to completion which will include equipment qualification activities such as development of change controls, protocols, test scripts, execution of testing, and documentation updates for small to medium-sized projects.  Interact with equipment vendors to scope and procure equipment needed for qualification. 

• Serve as a technical liaison between the facility and equipment vendors/material suppliers. Collaborate with operational leaders to ensure optimal equipment performance across operations. Represent the site's technical interests in external project discussions and provide expertise to cross-functional initiatives.

• Become a Subject Matter Expert (SME) to apply industry knowledge of equipment qualification methodologies in drug substance manufacturing. Ensure all qualifications activities meet cGMP requirements and industry standards

• Attend meetings to gather and report out on issues / opportunities existing on the shop floor.

• Actively develop, promote, and implement safe work practices to ensure safe working conditions for all employees.

CONTEXT OF THE JOB/MAJOR CHALLENGES

• The Manager, Continuous Improvement will identify, investigate, troubleshoot, and resolve issues that impact manufacturing process equipment.

• The Manager, Continuous Improvement is tasked with leading change. This position is responsible for collaborating with Operations and is expected to work effectively with other supporting functions such as Quality, Automation, Maintenance and Manufacturing Technology.

• The Manager, Continuous Improvement will provide operational and technical input to the Drug Substance Continuous Improvement team by direct participation and integration into factory operations. This is accomplished through presence on the shop floor.

• The Manager, Continuous Improvement will serve as the subject matter expert (SME) within the Drug Substance Continuous Improvement team for projects related to manufacturing process equipment.

• The Manager, Continuous Improvement will lead small/medium process improvement initiatives and other activities as assigned.  The Manager, Continuous Improvement will assist with troubleshooting of production equipment and may assist with investigating deviations.

• The ideal candidate will possess a demonstrated history of successful small project leadership including project planning, resource management, execution, and project closure, experience in the areas of customer support, operational excellence, and troubleshooting.

About You

Basic Qualifications

• Bachelor’s degree in Mechanical, Industrial, Manufacturing Engineering, or a related technical field

• Minimum of 3 years of experience in a regulated (regulatory) environment

• Strong understanding of current Good Manufacturing Practices (cGMP) and Continuous Improvement methodologies, with a proven track record of excellence in a technical or scientific role

• Excellent written and verbal communication skills, with the ability to actively and collaboratively lead cross-functional teams

Preferred Qualifications

• Certifications in Lean Manufacturing, Six Sigma, or similar methodologies are a plus

• Experience in writing, executing, and following up on equipment qualifications

• Additional technical certifications or training relevant to manufacturing or quality systems are advantageous

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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Pursue Progress. Discovery Extraordinary.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.