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Process Engineer III Job at Engineering & Maintenance at Sanofi

Location Framingham, Massachusetts Job Category Engineering & Maintenance Requisition Number POS_75113735-1
Process Engineer III-POS_75113735-1


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 III works in the Manufacturing Science and Technology group to provide expert technical support to Commercial Operations at the Framingham Biologics site.

He / she will:

Initiate, develop and support continuous improvement efforts from development of user needs through to process validation

Being an invaluable partner to the Manufacturing and Quality organizations in daily operations and maintaining the process in a reliable state of control

Real-time "process ownership"- i.e. process performance, yields, productivity

Expert process monitoring using a variety of data analysis methods/techniques for thorough and rigorous process characterization (excel, JMP, etc.,)

Providing expert technical support/analysis for the resolution deviations, investigations and process issues- recommendations for product disposition/CAPAs

Proactive identification and ownership of resolution of process issues

Supporting inspection readiness of the site

Completes technical investigations

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

Lend Expert technical support to GMP operations in a multi‐product cell culture and purification plant

Maintain process knowledge and ownership

Lead the proposal, initiation, testing and implementation of minor proposed changes to cell culture or purification processes

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



Qualifications

BASIC QUALIFICATIONS:

BS and 8 years of professional experience OR MS and 6 years of professional experience OR PhD and 2 years of professional experience with commercial scale protein purification in a cGMP manufacturing environment.

PREFFERED QUALIFICATIONS

Extensive experience in the scale up and operation of large scale biotechnology processes.
Hands‐on experience with large scale biotechnology unit operations.
Rigorous process development experience
In depth understanding of large scale biotechnology unit operations, principles of SIP and CIP, and principles of biochemical engineering, and process data analysis.
Full understanding of compliance and cGMP considerations.
Demonstrated commitment to continuous improvement – at the individual, department and organizational levels.

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:

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

• Act for Change – Creatively challenges the status quo to find new ways of working; looks for the opportunities that arise during times of change; readily adapts to new environment, jobs, technologies and processes



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


Job Posting : Feb 17, 2017, 1:06:22 AM

Job Type : Regular
Employee Status : Regular