Process Engineer II, MSAT

Job description

External Job Description

Position Title : Process Engineer II, MSAT

Job Overview:
The PE II works in the Manufacturing Science and Technology (MSAT) department as a technical leader providing support to Commercial Cell Culture Operations and technology transfer.

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, CPV, 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 II of 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 II MSAT:

·  Provide scientific/technical support, expertise, and guidance to commercial manufacturing at Sanofi/Partner/CMO sites including process monitoring, change assessment, and continuous improvement that result in safe, high quality products and continuously improving processes.
·  Provide technical leadership in process-related investigations. Anticipate, respond to, and permanently resolve issues that arise during production. Provide on-the-floor technical support if required.
·  Review production data and manufacturing processes. Lead process monitoring and continued process verification activities.
·  Generate conclusions based on data analysis and prepare presentations and reports to clearly communicate outcomes.
·  Partner with external and internal functions to identify, prioritize, transfer, implement, validate, and file product/process life cycle improvements.
·  Define relevant operational/technical standards and best practices for manufacturing sites.
·  Identify opportunities to debottleneck and maximize throughput and capacity utilization, and drive implementation of improvements.
·  Develop and act on individual development plan to remain current with technical and regulatory guidelines. Support documentation preparation to support regulatory activities.
·  Maintain and demonstrate knowledge of state-of-the-art principles and theories in area of responsibility.
·  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:

·  Degree(s) in Engineering, Biological Sciences or equivalent.
·  BSc with 3+ industry years or Masters with 1+ industry years.
·  Understand key elements of unit operations in a manufacturing environment.
·  Understand core concepts in biotechnology or pharmaceutical industry
·  Proficient in MS Office and data analysis

PREFERRED QUALIFICATIONS:

·  BSc with 5+ industry years or Masters with 3+ industry years or PhD with 1+.
·  Demonstrated expertise applying fundamental principles to real world problem solving and providing practical solutions to difficult technical issues
·  Strong verbal communication and technical writing skills. Experience communicating with business partners and senior management
·  Experience with cell culture or fermentation
·  Understand cGMP concept
·  Experience leading projects and/or cross functional teams
·  Proficient in process data analytics
·  Knowledge of Distributed Control System, Data Historian, LIMS, and MES

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:
PE II is an individual contributor role with no direct reporting responsibilities but the ideal candidate must be able to lead project teams independently. Standard business hours apply. The job may require occasional domestic or international travel.

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.

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.

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.