Sanofi Group Process Engineer II in Framingham, Massachusetts
Process Engineer II
Sanofi Genzyme focuses on developingspecialty treatments for debilitating diseases that are often difficult todiagnose and treat, providing hope to patients and their families.
Genzyme Corporation (a Sanofi company) and its U.S.affiliates are Equal Opportunity and Affirmative Action employers committed toa culturally diverse workforce. Allqualified applicants will receive consideration for employment without regardto race; color; creed; religion; national origin; age; ancestry; nationality;marital, domestic partnership or civil union status; sex, gender, genderidentity or expression; affectional or sexual orientation; disability; veteranor military status or liability for military status; domestic violence victimstatus; atypical cellular or blood trait; genetic information (including therefusal to submit to genetic testing) or any other characteristic protected bylaw.
Manufacturing Science and Technology (MSAT) is the keeper of thebody of manufacturing process knowledge, supports the creation of theinstruction set and ensures manufacturing operations stay aligned with theregistered process. MSAT is responsible for:
Providing daily on‐the‐floor technical support.
Providing technical leadership in process‐relatedinvestigations.
Overseeing and leading data management & monitoring/SPC reviewprocesses.
Developing strategy for process validation activities.
Maintaining the Process Control Strategy and Operating ControlStrategy.
Identifying and implementing commercial process/product life cycleimprovements.
Defining relevant operational/technical standards and practicesfor the site.
Identifying and driving implementation of improvements to maximizethroughput and capacity utilization.
Utilizing and maintaining robust scale down models to supportmanufacturing operations.
The primary objective is to ensure manufacturing processes arecapable, compliant, in control and continuously improved.
Position Overview and Key Responsibilities:
The Process Engineer II works in the Manufacturing Science andTechnology group to provide expert technical support to Commercial Operationsat the Framingham Biologics site.
This individual will work within the Manufacturing Science andTechnology organization with the following responsibilities:
Provide technical support to GMP operations in a multi‐product cell culture and purificationplant.Area of focus forthis position will be Media, Cell Expansion, Bioreactor, and Cell Banking.
Partner withManufacturing and Quality organizations in daily operations to maintain theprocess in a reliable state of control.
Develop processknowledge and ownership.
Perform processmonitoring using a variety of data analysis methods and techniques (e.g.,excel, JMP, etc.).
Providetechnical support and analysis for the resolution of deviations, investigationsand process issues.
Identify, ownand resolve process issues proactively.
Lead theproposal, initiation, testing and implementation of minor proposed changes tocell culture or purification processes.
Completestechnical investigations and provides on the floor technical expertise.
Generatedocuments (technical memos and reports, protocols, etc.,) related to processmonitoring programs and non‐conformances.
Participate incross functional initiatives.
An ongoing commitment to conducting our global business accordingto the highest legal and ethical standards, and to continually pursueexcellence in the development and delivery of all of our products and services.This includes:
Adhering to allapplicable laws and regulations of the places in which we conduct business, aswell as our own Company policies and procedures.
Being honest andtreating people with respect and courtesy.
Constantlystriving to make Genzyme a great place to work, and a company respected for thequality of its people and products.
Acting as rolemodels for our fellow employees by acting responsibly, fairly, and honestly inour dealings and exercising sound judgment in performing our jobs.
- BS inengineering with at least 3 years, orMS in engineering with at least 1 years or PhD with 0 yrs relevant experience in a cGMP manufacturing environment.
BS in chemical engineering/Biochemistry/Biotechnology/Biological sciences with 7 years, or MS in chemical engineering/Biochemistry/Biotechnology/Biological sciences with 5 years or PhD in chemical engineering/Biochemistry/Biotechnology/Biological sciences with 2 years of relevant experience in a cGMP manufacturing environment.
Hands-on experience in running, developing and troubleshooting protein purification, UF/DF, TFF, and filtration processes.
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.
Demonstrated commitment to continuous improvement – at the individual, department and organizational levels.
Experience with high level data analysis and strongtechnical 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.
Process development experience is highly desirable.
Publications in high impact journals.
Prior experience in leadership roles with direct reports (if any).
Experience in working with cross functional teams inhigh paced environment.
Job: Engineering & Maintenance
Primary Location: United States-Massachusetts-Framingham
Job Posting: Oct 18, 2016, 10:21:27 AM
Job Type: Regular
Employee Status: Regular