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Process Engineer III

Framingham, Massachusetts

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"One of the best things about Sanofi Genzyme is the consistently fun and dynamic work environment that I get to be a part of."

Kristin Ouimet Regional Business Manager

"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."

Shannon Resetich US Head Rare Diseases & Blood Disorders

"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."

Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

**Monday-Friday- 1st shift**

**Onsite position with flexibility to work remote when appropriate**

The Framingham Engineering, Projects & Controls organization is responsible for providing Engineering support to organizations on the Framingham campus. This organization is comprised of 3 groups: Engineering, Commissioning and Qualification and Projects and Controls.  

The Framingham Engineering, Projects & Controls organization will be supporting the following groups at the Framingham campus: (1) Framingham Biologics - comprised of commercial Fabrazyme, Thyrogen and Global Cell Banking operations. (2) Framingham Facilities Operations - responsible for campus wide facilities and utilities operations per established Service Level Agreements and (3) Framingham Campus - in the context of programs/projects requiring approval, planning and execution across the Sanofi groups on the Framingham campus. While each business has its own Engineering support group, the Framingham Engineering, Projects and Controls organization will interact with all of these groups on projects/programs with campus impact.

This organization is responsible for providing Engineering support for all cGMP process and utility systems at Framingham Biologics, maintaining these systems in a validated state of control and ensuring uninterrupted business continuity.  This organization is also responsible for shared GMP systems on the Framingham campus as defined by Service Level Agreements. The Capital Projects group is responsible for the planning and execution of projects and programs under its scope as determined by budget and other pre-established criteria, ensuring projects/programs are completed to established schedules and budget. The Commissioning and Qualification groups will be responsible for providing C&Q support to systems and projects/programs within the scope of this organization.

POSITION SUMMARY:

This position, with guidance, leads the engineering support of manufacturing, maintenance and capital projects.  It also develops, organizes analyzes and presents interpretation of results for operational issues or concurrent engineering projects of moderate scope and complexity.

CORE RESPONSIBILITIES:

  • Execute concurrent projects of moderate to extensive scope and complexity, with supervision, as required.

  • Interpret and execute policies and procedures.  Recommend modifications to operating policies.

  • Lead/participate with a group of engineers and/or technicians on an ongoing or project basis.

  • Actively participate and provide input and feedback for the Sanofi Safety Program to meet Health and Safety regulations and OSHA requirements in all duties.

  • Function as a technical expert on equipment and systems; lead troubleshooting of operations, develop preventative maintenance procedures, and maintain engineering documentation.

  • Routinely audit the operational performance and regulatory compliance of a large number of highly complex equipment components or systems.

  • Lead efforts with manufacturing, process development, facilities, quality assurance and other departments in developing requirements and recommendations for system modifications.

  • Execute tasks, under the minimal direction of project managers, to complete design, engineering, construction, commissioning and qualification for projects within schedule and budget constraints.

  • Coordinate the work of consultants, and engineering firms on development of standard design documents.

  • Develop project scopes, schedules and budgets.

  • Obtain and critique quotes for system/facility modifications and work with the vendor to execute.

  • Lead initiatives and/or projects.

  • Demonstrate skills in the following areas:
    o Schedule development
    o Facilitation
    o Collaboration
    o Basic project management
    o Completion and follow-up

  • Utilize quality systems to ensure compliance with regulatory requirements.

  • Partner with peers, team members, direct and indirect management chain to ensure the following:
    o Training plan execution
    o Ensure Inspection Readiness of assigned areas
    o Participate in timely completion of investigations, deviations and CAPA
    o Provide support for documentation changes
    o Develop and manage change controls

  • Comply with requirements from Sanofi’s Safety Program including Health and Safety regulations and OSHA requirements.

*Key responsibilities may differ among employees with the 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 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 Sanofi 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.

BASIC QUALIFICATIONS:

  • Bachelor’s degree in Engineering with 5+ years of relevant work experience including 3+ years of experience in Bio-Pharmaceuticals; or Master’s with 4+ years of relevant work experience with 2+ years of experience in Bio-Pharmaceuticals.

  • Direct experience with regulated environments (i.e., CGMP, OSHA, EPA).

  • General understanding of Quality Systems

  • Working knowledge of pharmaceutical/biotech processes.

PREFERRED QUALIFICATIONS:

  • Working knowledge of specialized equipment/processes.

  • General knowledge of Commissioning and Qualification

  • Effectively interact with a variety of communication and working styles.

  • Ability to independently determine when additional internal/external resources are required to solve problems.

  • General knowledge of other related disciplines.

  • General understanding and wide application of technical principle, theories and concepts in the Biotech/Pharmaceutical field.

  • Demonstrated skills in the following areas:
    o Problem solving and applied engineering
    o Basic technical report writing 

  • Ability to gown and gain entry to manufacturing areas.

  • Required to support manufacturing operations on an “on call” 24/7 basis

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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