Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Automation Engineer II - Automation Engineering Group
Automation Engineer for the Automation Engineering (AE) group in the Manufacturing Systems & IT Organization for Framingham Biologics, providing support for on-going commercial manufacturing. Role is expected to serve as a support engineer for growing automation group, supporting process, utility, and building automation systems used in commercial production. This position requires experience in working within cGMP operations, especially regarding change control and other quality systems. The candidate must be technically proficient in both hardware and software aspects of control systems, primarily the Emerson Process Management DeltaV product. This position will also be responsible for the following:
Maintaining and supporting all control systems at existing 24x7 manufacturing sites, ensuring they remain available and in a validated state.
Executing or overseeing all changes occurring on validated control systems, ensuring all work is documented and executed per applicable procedures.
Maintaining up to date and correct functional requirements and detailed design documents for equipment controlled by the control systems
Executing a variety of deliverables for the AE group, which include continuous improvement projects, change control implementation, deviation closure, and CAPA
Working directly with internal customers (facilities, engineering, manufacturing, etc) to gather user and functional requirements for impacted systems.
Ensuring timely and full resolution of AE related process/equipment/manufacturing issues.
Maintaining systems-related SOPs and training program development support
5-7 years of automation experience in a cGMP operations environment including batch and continuous control applications.
Knowledge of standards such as GAMP and S88, operations support experience, and validation experience of these systems
DCS control systems (DeltaV system) and associated systems (such as historians) experience
BS/MS in an Engineering discipline
Experience in a GMP operations environment or in other regulated environments
Building Automation and PLC experience
OSI/PI data historian experience
Controls hardware and instrumentation experience
Proven technical and analytical skills to quickly troubleshoot and resolve issues
Excellent interpersonal and communication skills
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