Process Engineer Senior Job in Framingham, Massachusetts US
Process Engineer Senior
Description
Description
Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzyme's people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortune's list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzyme's local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success
Senior Process Engineer - MES
The Senior Process Engineer for the MES group in the Manufacturing Systems Organization for Framingham Biologics, tasked with delivering robust, integrated MES solutions in accordance with the site business plan. Candidate is expected to serve as site lead for MES across the organization. This position requires in-depth experience and understanding of manufacturing operations, from the operating floor, up through the business reporting systems (ERP). The candidate must be technically proficient in MES systems, integration with ERP, DCS and other systems. The candidate should also have an understanding of the Biotech manufacturing process for supporting day to day activities and site operations. This position will also be responsible for the following:
- Designing MES systems and driving requirements with detailed designs with Vendors.
- Meet with internal customers to understand requirements and provide a system that provides a high ROI and eliminates manual data entry and errors.
- Assist in developing and updating MES strategy documents, ensuring alignment with site business planning.
- Working directly with internal customers (manufacturing, quality, engineering, facilities, etc) to prioritize and plan projects and establish user and functional requirements as needed.
- Establish and maintain site design standards for MES, including both hardware and software standards.
- Provide routine status updates on projects to management.
- Provide guidance and input into the CAPA process to help design out repeat deviations and exceptions.
- Interacts with counterparts form other sites outside of Framingham to ensure alignment for major integration initiatives.
Qualifications
Basic Requirements:
- 5+ years of MES experience in a cGMP operations environment
- Strong understanding of automation systems - MES and DeltaV
- Knowledge of standards such as GAMP, S88, S95, and validation experience of automation systems
- Strong communication skills both verbal and written
- BS/MS in an Engineering discipline
Preferred Requirements:
- Experience with Werum PAS-X, MES
- Excellent organizational, interpersonal and communication skills
- Self-motivated and able to function well in a fast-paced multi-tasking environment.
- Knowledge of other Plant information systems such as OSI PI Historian, LIMS is a plus.
- Working knowledge of ERP-MES integration and S95 concepts.
- Working knowledge of GMP regulatory requirements
