Job title: Quality Continuous Improvement
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.
Provides leadership and technical engineering expertise for quality processes, procedures, troubleshooting, investigations, improvement projects, capas and change controls.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
Leads continuous improvement (CI) projects to identify the sources of manufacturing process variability, design and implement engineering solutions to improve.
Leads / supports technical investigations into production defects including the resulting design and implementation of engineering solutions.
Leads Failure Mode and Effects Analysis (FMEA) assessments on new biotech manufacturing systems and supports designing appropriate controls.
Collaborates with the Engineering Dept on engineering and automation controls and testing associated with new equipment and facilities.
Collaborates with Manufacturing Science and Analytical Technology (MSAT) on technical projects associated with process development and validation.
Provides quality engineering input into engineering designs for new equipment and processes.
Leads / supports quality continuous improvement projects to improve process reliability and reduce cost. 20%
Leads / supports pro-active risk management processes such as FMEA to identify areas of potential failure and design / implement system controls as needed. 20%
Leads / supports technical quality investigations driven by quality events. 20%
Provides Quality input and oversight into design, testing and validation activities carried out by the Engineering and MSAT departments. 20%
Collaborates within site(s) and across the sanofi network as required on Quality Engineering topics. 20%
Scope and dimensions
Breadth of responsibility (global/regional/country/site): Swiftwater and Protein Sciences Sites
Key dimensions: Project PKMs, KPIs, Cost, Defects
Key performance indicators: process reliability, PPKs, defect rates, Quality metrics, cost reduction
Interact successfully within the highly energized production and regulatory environments.
Freedom to act, level of autonomy: high degree of autonomy and is expected to make decisions and interpretations within broadly defined requirements
Headcount management: No direct reports
About You
Education and experience
A minimum bachelor’s degree in Engineering or related field with 1-4 years of cGMP experience.
Basic understanding of biotech / vaccine manufacturing processes
Basic understanding of quality principles such as Quality by Design
Competencies –
the jobholder will be evaluated on 4 key competencies: Act for Change, Strive for Results, Communicate Transversally, Commit to Customers.
Key Technical Competencies and Soft Skills:
Basic understanding of cGMPs
Strong basic engineering technical skills
Strong analytical skills and problem solving
Ability to collect, evaluate and summarize data effectively
Strong written and oral communication skills
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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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 and check out our Diversity Equity and Inclusion actions at sanofi.com!
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.
North America Applicants Only
The salary range for this position is:
$67,500.00 - $97,500.00All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.