Job Title: Manufacturing Compliance Engineer II
Location : Framingham, MA
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.
Manufacturing Operations is responsible for supporting large scale mammalian cell culture and multi-stage large scale chromatography manufacturing operations as part of a 24/7 large-scale therapeutic protein or vaccine manufacturing facility. Operation's main functions are leading deviation investigations and managing CAPA Implementation, partnering with direct manufacturing staff for enhancing and improving the manufacturing instruction set, overseeing and supporting manufacturing's traini8ng program, and identifying and managing continuous improvement initiatives.
Manufacturing Compliance Engineer II uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within manufacturing operations.
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
Practices safe work habits and adheres to Sanofi's safety procedures and guidelines.
Participates on cross functional teams to drive investigation close outs, determine root cause and implement appropriate Corrective and Presentative Action.
Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive changes.
Conducts document revisions and/or document management including batch production records, and manufacturing procedures.
Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory, and compliance.
Organizes and participates on cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services.
Works independently with minimal supervision and direction.
Participates in determining objectives of assignment.
Performs work that consistently requires independent decision making and exercise of independent judgement and discretion.
Effectively utilizes Microsoft office applications.
Uses basic technical knowledge to analyze and evaluate data in order to provide reliable information, ensure project delivery and to execute routine tasks within well defined business practices and guidelines.
Responds to specific technical/administrative inquires and provides a comprehensive level of customer satisfaction.
Works within an established team environment, advise and assist team members to facilitate the achievement of their objectives.
Partners with co-workers and external customers across a local function or business area to achieve desired results, escalating and coordinating the resolution of routine issues.
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
About You
An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services. This includes:
Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Sanofi's a great place to work and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs
Skills/Experience/Education
High school diploma or GED with 5+ years of experience in a cGXP manufacturing environment or a bachelor's degree in sciences, Technical, Engineering with minimum of 2-3 years of experience in a cGXP manufacturing environment or a master's degree with 1 year experience in a cGXP manufacturing environment
Demonstrate knowledge / understanding of Manufacturing.
Knowledge of GXP regulations and guidance.
Experience with change control requests, CAPAs and deviation quality systems.
Demonstrate proficiency in critical thinking and technical writing.
Excellent written and oral English language skills.
Balances the speed of delivering work with quality and shows commitment to make improvements in both aspects.
·Keeps tasks (deviations, CAPA, or CCR) on schedule, tracks them carefully, and delivers results on time; seeks assistance to solve a problem quickly to adhere to ontime delivery
Ability to adapt in a fast paced environment.
Bachelor's degree in Biology, Chemistry, Biochemistry, or Chemical Engineering.
Ability to influence in a cross-functional environment.
Experience facilitating meetings.
Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.
Familiarity with Deviation Management Systems (e.g. Trackwise).
Experience in troubleshooting, investigation, and root cause analysis in a GXP environment.
Operations experience in one or more of the following areas: Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, or Automation.
Ability to gown and gain entry to manufacturing areas.
Ability to work offshift hours, seldom, to support product release
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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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.
North America Applicants Only
The salary range for this position is:
$67,500.00 - $97,500.00
All 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 (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .
Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)
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)
