Process Engineer II

Job description

Position Overview:

The Process Engineering organization supports the Biologics/Biosurgery Divisions consisting of GMP operations at the Genzyme 74/76 NYA Manufacturing Facility. This division of Sanofi contains approximately 120 employees, with site functions ranging from Quality Assurance, Quality Control, Quality Engineering, Manufacturing, and Materials Management organizations.

The Process Engineer II will serve as a Subject Matter Expert (SME) for multiple unit operations. The Process Engineer II will support process monitoring, data trending and provide on-the-floor process troubleshooting as needed. Additionally, the individual will support completion Quality System
requirements. The position will require the technical expertise application in the implementation of often complex, non-routine projects involving the application of planning, design and process knowledge skills.
The Process Engineer II will identify the opportunity, quantify the cost benefit of the improvement and will drive the change control process.

The key functions of this position include manufacturing technical support and long-term process improvements. This individual will work with a cross-functional team within Genzyme. 

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Issue technical and investigational reports.

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Provide lead technical support for specific unit operations within a manufacturing process.

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Provide technical support on manufacturing deviations and investigations. Through root cause analysis, provide corrective solutions.

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Identify and lead the implementation of moderate scope process improvements.

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Support or lead monitoring and analysis of process performance and product quality data on a periodic basis.

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Provide leadership for moderate scope change controls.

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Design and execute experimental protocols.

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Comply with requirements from Genzyme’s Safety Program including Health and Safety regulations and OSHA requirements.

Major Responsibilities:

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Apply sound engineering theory and critical thinking to effectively resolve a variety of technical problems of moderate to large complexity and scope.

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Monitor and trend process data to detect potential processing issues and to ensure effective process control.

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Employ statistical analysis tools determine root cause for process anomalies and deviations.

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Support process investigations, deviations, CAPAs and Change Control events.

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Implement process improvements using effective benefit and risk analysis supported by applying data analysis and effective planning.

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Ensure safety and environmental measures are taken and appropriately addressed throughout the project.

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Provide support to Technology Transfer projects as needed.

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Serve as a peer-recognized subject matter expert in applicable manufacturing unit operations.

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Actively participate and provide input, feedback for Sanofi safety program to meet health and safety regulations and OSHA requirements.

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Understand regulatory and compliance trends in the industry to assess current compliance and gaps. Support gap remediation.

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Participate in both internal and external audits as and subject matter expert (SME) Provide on-the-floor support and troubleshooting as needed.

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Support continuous process validation by through the periodic analysis of process and product data.

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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 our products and services, including:

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Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.

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Being honest and treating people with respect and courtesy.

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Constantly striving to make Sanofi a great place to work and a company respected for the quality of its people and products.

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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.

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: 

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Respecting the laws and operating within the applicable 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. 

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Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products. 

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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.

Basic Qualifications:

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Bachelor’s Degree in Chemical Engineering or related engineering and science degree with 3 years of industry experience or a Master’s Degree with 1 years relevant experience.

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Excellent communication and technical writing skills.

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Demonstrated problem solving / trouble shooting skills.

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Direct experience working in regulated environments, i.e., cGMP, OSHA, and EPA.

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Candidate must be highly organized, flexible and adept at handling multiple projects with tight deadlines.

Preferred Qualifications:

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Experience with Statistical Process control and statistical analysis tools is desirable.

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Proven experience in people management, strategic planning, risk management, and change management

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Prior experience in the biopharmaceutical and or medical device industry is highly desirable.

Special Working Conditions:

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Ability to gown and gain entry to manufacturing areas is required.

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Access to mechanical areas and rooftops may require climbing ladders of modest height.

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.