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Title: Principal Engineer, Global Automation
Location: United States-Massachusetts-Framingham
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 atwww.genzyme.com.
Principal Engineer, Global Automation
We are seeking a highly motivated, highly organized, self-directed and flexible individual who can lead and set direction, demonstrating broad depth of knowledge in Automation Engineering. The successful candidate will report to the Director of Global Engineering. This position is based in Framingham, Massachusetts and requires the ability to manage within a complex, fast paced, dynamic and highly matrixed global environment.
The successful candidate will be responsible for the development, implementation and management of the Global Automation Engineering program at Genzyme, development and management of the Global Engineering Automation Team, and management and provision of technical support to projects and site engineering teams as required.
Global Automation Program Development and Management
The focus of the Global Automation program will lie in several key areas meant to establish integrated solutions to optimize production, ensure compliance while integrating a common control philosophy and operational platform, and contribute to shaping future technology using the understanding of the future business requirements, in parallel with providing current solutions.
The successful candidate will be expected to quickly engage with key stakeholders - internal and external, to clearly identify the critical issues and formulate solutions that will deliver value to the business. This should be done in a proactive way that involves the stakeholder in the development of the best value engineering solution, which meets the stakeholder's needs. The engineer will establish and clearly communicate business goals for entire global network in a framework that the individual members of the network can understand relative to their accountabilities and expectations for achievement of those goals. The successful candidate will direct performance, manage the global network, develop key strategies and work collaboratively with project teams and sites. A key skill in the role is the ability to incorporate the business needs and constraints with the end users needs. It is essential that successful candidate demonstrate leadership and foster collaboration within the network and develop a strong relationship with Genzyme personnel and supporting contractors.
Global Automation Team Development and Management
The successful candidate will establish the foundation of technical subject matter experts to allow the Global Automation Engineering network to deliver automated solutions cost effectively by utilizing re-useable automation standards, practices and specifications for projects, ensuring modular configuration, robust infrastructure and ease of end-user maintenance. The candidate will exhibit passion for providing end-to-end systems rather than single point solutions, understanding and ensuring compliance with international regulations and adherence to Genzyme quality standards. This individual will also establish and ensure the maintenance of communication channels that will encourage and facilitate a standardized approach to automation across the corporation. This individual will define the team structure, and identify and manage the Subject Matter Experts from within the Global Engineering organization, within the corporate network, or using external resources, as appropriate.
Global Automation Technical Support
In this role, the successful candidate will be responsible for providing technical support to projects or site engineers, as required. The individual will assess and manage risk effectively such that projects progress to meet the business needs. These risks may be assessed and managed with limited information, and under time constraints associated with responsibility for multiple projects. It is vital that the successful candidate have the ability to create an environment in which the project team is empowered to make decisions and move projects forward.
The Principal Engineer is responsible for providing direction and technical leadership for the design and development of automation and control systems, including engineering, startup, commissioning and qualification of HVAC, utilities, and process systems to support fermentation, purification, formulation, filling, warehouse QC lab operations. Additionally, the Principal Engineer will be responsible for leading the Global Engineering Automation Network to address complex problems on highly automated equipment, to understand both electrical and mechanical systems DCS and PLC programming (Rockwell Software, Siemens S7, Elau and/or Emerson DeltaV experience a plus), theoretical and applied knowledge of process instrumentation, classical process control, continuous process control, and S88 Batch programming, validation and GMP regulations applicable to automated systems (including ISPE GAMP guidelines), ISA standards and P&ID nomenclature, review of instrumentation and electrical wiring diagrams, communication networks, installation and troubleshooting.
Travel will be required both domestically and internationally. Some weekend travel may be required.
* BS or MS degree in an Engineering discipline with a minimum of 12-15 years of progressive experience in the Biotechnology, Biopharmaceutical or Pharmaceutical industries
Successful Candidates Must Also Possess:
* Design experience or owners experience in control systems for plant utilities, process equipment and clean utilities
* Knowledge of Process Control Instrumentation, Control Panel design, and Control System design
* Experience applying S88 and S95 ISA standards is well as ISPE GAMP standards
* Experience in leading and/or influencing multi-disciplinary global groups in a fast paced changeable environment
* Strong leadership, relationship management, and organizational planning and project management skills, in addition to technical knowledge
* Ability to influence sites, suppliers and colleagues into adopting "best practice" and a proven track record of building and growing "best in class" engineering teams
* Mammalian Cell Culture experience
* Experience in utility, facility, and equipment design and operation, as well as experience in cGMP manufacturing environments related to the design of equipment, to maintain sterile operations
* Excellent communication skills - verbal, written, listening and interpersonal with the ablilty to transfer knowledge to others portraying confidence to sites globally that you and your team are the experts and can deliver
* Good Supplier Relationship Management competence will be required
* Attentive to cultural sensitivities
* Experience with Delta V control systems and OSI PI information management systems
* Working experience with manufacturing execution systems
* Experience in the development of automation technology
* Working knowledge of processing steps, including fermentation, purification, formulation, and filling as well as API processing