Massachusetts Jobs

Job Title: Manufacturing Compliance Engineer I

Location: Swiftwater, PA

About the Job

This is a Monday to Friday morning shift with a Saturday weekend requirement

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. Your job, as a Production Operator within our Formulation and Filling Team, will have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

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?

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. Operations’ 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 training program, and identifying and managing continuous improvement initiatives.

Manufacturing Compliance Engineer I uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within manufacturing operations.

Core Responsibilities

• Practices safe work habits and adheres to Sanofi’s safety procedures and guidelines.

• Participates on cross functional teams and drive investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.

• Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change.

• 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 on process operations, theory, and compliance.

• Participates on cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services.

• Works under general supervision and direction.

• Participates in determining objectives of assignment.

• Performs work that may require independent decision making and the 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.

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

About you

• Bachelor's degree in Sciences, Technical, Engineering with 0-2 years of experience in a cGXP manufacturing environment.

• Understanding of GXP and how it applies to specific responsibilities.

• Excellent written and oral English language skills.

• Ability to adapt in a fast paced environment.

• Bachelor’s degree in Biology, Chemistry, Biochemistry, or Chemical Engineering.

• 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 troubles shooting investigation, and root cause analysis in a GXP environment.

• Experience in critical thinking and technical writing

• Experience with deviation or investigation management systems.

• 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 on time delivery

• Ability to gown and gain entry to manufacturing areas.

• Ability to work off shift 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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