Process Engineer I
Sanofi
Allston, MA
Job Overview:
The Process Engineer works in the Manufacturing Science and Technology (MSAT) department as a technical leader providing support to Commercial Cell Culture Operations and technology transfer at the Allston Landing or Framingham Biologics Facilities.

Department Description:
Manufacturing Science is a partner of biologics manufacturing operations and is the custodian of manufacturing processes. Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.

Provide collocated technical leadership at manufacturing sites including process monitoring, continuous process verification, root cause investigation, change assessment, debottlenecking, and continuous improvement
Anticipate, respond to, and permanently resolve issues that arise during production.
Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.
Lead the creation and use of digital process data analytic systems.
Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.

Position Overview/Key Responsibilities:
The Process Engineer within Manufacturing Science and Technology (MSAT) is responsible for providing technical support to Sanofi Biologics cell culture operations as a member of Manufacturing Science Cell Culture team. The Process Engineer:

Assists in the review of GMP manufacturing processes and/or development data.
Helps formulate recommendations to improve quality, productivity, recovery, and efficiency.
May train manufacturing staff on new or changed processes and the use of equipment.
Contributes to the preparation of technical and investigation reports and other project documentation.
Interacts with colleagues from various functions, such as engineering, manufacturing, and quality departments.
Perform process monitoring using a variety of data analysis methods and techniques (e.g., excel, JMP, etc.).
Provide technical support and analysis for the resolution of deviations, investigations and process issues.
May work with contract manufacturing organizations providing technical support
This is a full-time job with expectation to work during regular business hours with occasional on-call responsibility. The job may require occasional domestic or international travel.

Requirements & Qualifications

BASIC QUALIFICATIONS:
Bachelor’s degree in science or engineering with 1 year of experience or Master’s degree in science or engineering

PREFERRED QUALIFICATIONS (any of the items listed below is desired):

Knowledge of large-scale biotechnology unit operations, principles of SIP and CIP, principles of biochemical engineering, and process data analysis.
Understanding of compliance and cGMP considerations.
Process development experience is highly desirable.
Demonstrated commitment to continuous improvement – at the individual, department and organizational levels.
Experience with high level data analysis and strong technical writing and presentation skills.
Experience in the scale up and operation of large-scale biotechnology processes.
Hands-on experience with large scale biotechnology unit operations.
Publications in high impact journals.
Experience in working with cross functional teams in high paced environment.

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.
  • Strives for results – sets ambitious tangible and measurable targets ; takes personal responsibility for achieving results; reviews and evaluates progress against agreed targets, timelines and budgets
  • Cooperates transversally – Shares information and seeks input from outside direct team. Develops strong cross functional relationships and partnerships with science and commercial organization
  • Commit to customers- Shares relevant information openly and seeks appropriate input from others outside of the direct team; develops and maintains effective cross-functional working relationships and partnerships; responds positively and constructively to requests for support from across the organization
Terms of employment:
PE1 is an individual contributor role with no direct reporting responsibilities.Standard business hours apply and routine travel is not expected.

What makes this position unique?
Manufacturing Science and Technology (MSAT) is the keeper of the body of manufacturing process knowledge, supports the creation of the instruction set and ensures manufacturing operations stay aligned with the registered process. The primary objective is to ensure manufacturing processes are capable, compliant, in control and continuously improved. MSAT owns process validation, process control strategy definition, process monitoring, and commercial process improvements for lifecycle management.

Benefits of working in this role:
Cross-functional team collaboration provides visibility and exposure to multiple areas in the organization.
Sanofi actively encourages internal career development growth opportunities.

Location information:
This position will be based in Allston or Framingham, MA. Occasional visits to other locations may be required.

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Location information:
This position will be based in Allston or Framingham, MA. Occasional visits to other locations may be required.

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.