Location(s): United States; Massachusetts; Westborough
About Us: What do you envision for your future? At GE Healthcare, we strive to see life more clearly. Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing healthcare costs, increasing access and improving quality and efficiency around the world.
We are an $18 billion unit of General Electric Company (NYSE: GE), employing more than 52,000 people worldwide and serving healthcare professionals in more than 100 countries. We believe in our strategy - and we'd like you to be a part of it. As a global leader, GE can bring together the best in science, technology, business and people to help solve one of the world's toughest challenges and shape a new age of healthcare.
Something remarkable happens when you bring together people who are committed to making a difference - they do!
GE Healthcare Life Sciences provides products and services used as tools for biopharmaceutical manufacturing, drug discovery and the latest in cellular technologies, thereby enabling our customers around the world to be more productive, effective and creative. Our motivation is to create better health for more people. Through our five decades of supporting the biopharmaceutical industry and its research partners to become more productive, we are helping to reduce costs, increase access and improve quality in the healthcare system. We use our expertise and know-how in imaginative ways to work with our customers to provide what’s needed today and create products and solutions to enable the medical treatments of tomorrow. We add value to our customers by:
Providing cutting-edge research tools that give deeper insights into cell function to enable disease diagnosis and the development of treatments.
Enabling manufacturing productivity: we provide solutions for the entire bioprocess workflow (i.e. start-to-finish bioprocessing) helping our customers to develop and manufacture biopharmaceuticals more efficiently.
Providing high quality support and maintenance services.
We are the home of many famous brands, including Whatman, Amersham, Biacore, WAVE, Applied Precision, Xcellerex and more.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Role Summary: The enterprise solutions organization is an initiative within GE Life Sciences that focus on establishing biopharmaceutical manufacturing capacity for customers. By leveraging on the business units extensive product portfolio and process know-how the aim is to sell projects to customers who wants to set up their own manufacturing plant.
Essential Responsibilities: The enterprise solutions organization is looking for a Lead System Designer (LSD) to lead system design for the FlexFactory single-use manufacturing system. The LSD will be accountable for the system design of the FlexFactory, automated equipment assembly, and will ensure compliance with the applicable regulatory requirements; optimized performance for the customer’s process, operation, facility layout and regional location.
Essential Responsibilities The Lead System designer will be responsible for the FlexFactory system design which includes but not limited to the generation of relevant design documents including Process Flow Diagrams (PFDs), equipment lists, utility requirements, process descriptions, user requirements specification (URS), general specification (GS), equipment configurations and design approval packages for the FlexFactory components. The Lead System Designer will be responsible for providing feasible, reliable and profitable macro level design based on customer needs and regulatory requirements. Has overall design responsibility for the FlexFactory equipment, consumable and accessory selection and specification, utility requirements, automation requirements, design documentation generation, testing protocol review and approval. Lead the design control process from requirements development and design planning to final design approval by customer. Ensure applicable customer requirements specification (URS) can be met by the FlexFactory design, and ultimately fulfilled by the end product. Initiate the FlexFactory equipment product code registration. Interface and coordinate with a cross-functional team of engineers, Process Design Engineers and customer. Support Manufacturing Group to ensure the completeness of the TOP, equipment set-up for Functional Testing & FAT. Support Customers questions/issues during Factory Acceptance Test (FAT) and manage FAT deviation punch list. Coordinate the detailed design and solve any design issues during the design phase and acts as a contract for system design related questions. Participates in developing and updating the FlexFactory project schedule.
Duties include: Support customer meetings by providing system hardware understanding. Develop, explore and recommend manufacturing concepts to fit customer needs/facility requirements.
Assure compliance with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
Work closely with Customer’s Subject Matter Experts (SMEs) to ensure continuous exchange of critical and technical information needed to execute design activities on time
Complete all planned Quality & Compliance training within defined deadlines
Identify and report any quality or compliance concerns and take immediate corrective action as required
Work closely with Process Design Engineers to ensure that the equipment specification meets customer and process needs, and that equipment layout is optimized for the customer facility.
Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones
Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Approximately 10-30% travel depending on project specifics and geographic location
BS or MS degree in biochemical / chemical engineering or a related engineering/life Science discipline
Minimum of 5 years of relevant bioprocess experience
Working knowledge of pharmaceutical/biotech processes, equipment hardware, and signle use technology
Thorough knowledge of biologics CMC, cGMP manufacturing requirements
Technical understanding of automation systems used in the biopharma (Delta V, PLC, PI, etc.)
Experience in working/leading within cross functional teams
Experience with AutoCAD, Visio, MS Project, SuperPro
Fluent in English both verbally and in writing
Disposable technology design and application experience
2 years of direct experience working in a pilot plant or GMP manufacturing facility
Detail oriented, excellent at critical analysis and problem solving
Experience working in global business environment with sound understanding of global processes
Open to a changing environment
Structured, organized, Analytical, Team oriented
Locations: United States; Massachusetts; Westborough
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