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Process Engineer I Job at Engineering & Maintenance at Sanofi

Location Framingham, Massachusetts Job Category Engineering & Maintenance Requisition Number POS_75112198-1
Process Engineer I-POS_75112198-1


Description
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.

Genzyme Corporation (a Sanofi company) 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.


DEPARTMENT DESCRIPTION:


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. MSAT provides technical and logistical support to Framingham biologics manufacturing facilities. The primary objective is to ensure manufacturing processes are in control, capable, compliant and continuously improved.

MSAT is responsible for:

• Providing technical leadership in process-related investigations.

• Providing on the floor technical support and troubleshooting.

• Developing strategy for process validation activities.

• Provide input to the Process Control Strategy and Operational Control Strategy.

• Identifying and implementing commercial process/product life cycle improvements.

• Defining relevant operational/technical standards and practices for the site.

• Identifying and driving implementation of improvements to maximize throughput and capacity utilization.

• Lead the proposal, initiation, testing and implementation of minor proposed changes to purification processes.

• Develop, transfer and maintain robust scale down models to support manufacturing operations.

• Utilize this knowledge to effectively support root cause analysis, process validation, implementation of process improvements, and improvements in process control strategies.

POSITION OVERVIEW / KEY RESPONSIBILITIES*:

The Process Engineer I works in the Manufacturing Science group to provide expert technical support to Commercial Operations at the Framingham Biologics site. This includes, but is not limited to, experimental support for deviations or manufacturing investigations; process troubleshooting, raw material evaluation, Planning and execution of validation programs, continuous process monitoring and improvement. This person is also responsible for analyzing and drawing accurate conclusions and recommendations from the process and experimental data. He / she will:

• Provide technical and logistical support to GMP operations in a multi-product cell culture and purification plant.

• Partner with Manufacturing and Quality organizations in daily operations to maintain the process in a reliable state of control.

• Interact with MSAT colleagues from other sites and CMOs as needed.
Develop process knowledge and ownership.

• 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.

• Identify, own and resolve process issues proactively.

• Lead the proposal, initiation, testing and implementation of minor proposed changes to purification processes.

• Completes technical investigations and provides technical expertise.

• Generate documents (technical memos and reports, protocols, etc.,) related to process monitoring programs and non-conformances.

• Participate in cross functional initiatives.

• Keep abreast of new developments/technologies in areas of responsibility.

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


Qualifications
BASIC QUALIFICATIONS:

BSc in Chemical Engineering / Biochemistry / Biotechnology / Biological Sciences with 1 - 4 years experience in a cGMP manufacturing environment
OR Masters in Chemical Engineering / Biochemistry / Biotechnology / Biological Sciences with 0 - 2 years of relevant experience in a cGMP manufacturing environment.

Hands-on experience in running, developing and troubleshooting protein purification 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 strong technical writing and presentation skills.

PREFFERED QUALIFICATIONS:

Hands-on experience with large scale biotechnology unit operations.
Process development experience is highly desirable.
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.

• Think strategically - Think and plan broadly and long-term to inspire excellence in execution.

• Cooperates transversally – Shares information and seeks input from outside direct team. Develops strong cross functional relationships and partnerships with science and commercial organization.


• Act for Change – Creatively challenges the status quo to find new ways of working.

• Lead teams- Encourage collaboration and communication within and beyond the team. #LI-GZ



Job : Engineering & Maintenance
Primary Location : United States-Massachusetts-Framingham


Job Posting : Feb 17, 2017, 1:10:16 AM

Job Type : Regular
Employee Status : Regular