Compliance Engineer II

Job Title: Compliance Engineer II

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. Your job, as Manufacturing Compliance Engineer II within our Manufacturing Specialist Team, will do Deviation Writing/Investigation.​

Manufacturing Operations is responsible for supporting large scale mammalian cell culture and multi-stage chromatography as part of a 24/7 large scale therapeutic protein manufacturing facility. The Manufacturing Specialist Organization’s main functions are leading deviation investigations, managing CAPA and change implementation, partnering with direct manufacturing staff for improving manufacturing operations, overseeing and supporting manufacturing’s training program, and identifying and managing continuous improvement initiatives.

You are a flexible learner who can take on multiple aspects of Manufacturing Operations. You have the ability to work across the organization to influence the Manufacturing Cultural and ensure adherence to procedures and GMP processes. You excel in a fast-paced and dynamic environment requiring problem solving and attention to detail. You enjoy working in a collaborative and supportive team setting.

Our Framingham facility is located within a suburban community about 20 miles west of Boston in beautiful affordable Central Massachusetts with convenient highway access, free on-campus parking, and available shuttle service. Our campus complex currently incorporates thirteen buildings as part of our R&D and Manufacturing Operations.  Sanofi recently completed a multi-year capital expansion with several buildings constructed using “green” technology and resources including the 8 New York Avenue location which was recently heralded as the International Society Process Engineers (ISPE) Factory of the Year.

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

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:

The Manufacturing Specialist II uses expert knowledge of compliance and GXP manufacturing processes to manage minor/complex investigations and improvement initiatives within biologics and/or biosurgery.

• Practices and promotes safe work habits and adheres to Genzyme's safety procedures and guidelines.

• Manages cross functional teams to drive complex 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 complex document revisions and/or document management including batch production records, manufacturing procedures, and cross functional procedures.

• Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory, and compliance.

• Performs training with staff on the floor, as needed.

• Trains new Manufacturing Specialists.

• Leads cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Science and Technology.

• Works independently with minimal supervision and direction.

• Participates in determining objectives of assignment.

• Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

• Effectively utilizes Microsoft office applications.

• Creates and presents trending and metrics reports.

• Provides direction to the Manufacturing Specialist in the absence of the operations manager.

* Key responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

**The Framingham campus is hiring Manufacturing Specialists under levels I, II, III. The job description below encompasses all levels but the basic qualifications will indicate required years' of experience for each level**

**Strong technical writing skills, experience with deviations, CAPA's, and change control**

**Leads cross-functional teams including working with Engineering, Validation, QA, QC, Facilities, Metrology, and MSAT**

About you

Basic Qualifications  

• Bachelor's degree in Sciences, Technical, Engineering or Advanced degree with minimum of 2-3 years of 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.

Preferred Qualifications  

• 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.

Special Working Conditions  

• Ability to gown and gain entry to manufacturing areas.

• Ability to work offshift hours, seldom, to support product release 

LEADERSHIP QUALIFICATIONS:

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 of 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 Genzyme 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.

Leading People:

• Genzyme's leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers.

Leading the Business:

• Genzyme's leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement.

Delivering to Customers:

• Genzyme's leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence.

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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