Healthcare Life Sciences
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!
At work for a healthier world.
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GE Healthcare Life Sciencesprovides 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.
Learn More About GE Healthcare Life Sciences
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual 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.
Posted Position Title
Project Manager - FlexFactory Implementation - USCAN
Location(s) Where Opening Is Available United States
U.S. State, China or Canada Provinces
The Project Manager role at GE Healthcare Life Sciences will focus on a growing business segment: GE Healthcare Life Sciences - Enterprise Solutions & Services. The successful candidate will have oversight for complete site implementation and qualification activities for the Life Sciences product portfolio including Enterprise Solutions (FlexFactory) to meet customer needs.
The Enterprise Solutions & Services deliver turnkey Vaccine/MaB factories called FlexFactory™, which is based on single use principles, the FlexFactory typically consist of 80-90% GE equipment. Turnkey is understood as Installation, Calibration, Site Acceptance test and IQ-OQ of delivered equipment before handed over to customers. The FlexFactory™ can also be a part of GE's KuBio™ which is a modular built factory building.
The candidate has to be able to manage the interactions in a matrix/cross-functional organization structure in order to ensure timely execution of implementation and validation activities.
The Project Manager will report into the Enterprise Service Leader who is globally responsible for the implementation of FlexFactory.
Key Responsibilities / Essential Functions:
• Project Management for FlexFactory implementations.
• Be at customer's site during the FlexFactory implementation.
• Develop and improve processes around implementation in coordination with Enterprise Service Leader and the Enterprise Operations team
• Coordination of resources and cross functional activities as needed to meet project deadlines.
• Support delivery of Implementation plans and related documentation according to customer specific project plans.
• Drive customer satisfaction and product quality improvements; address manufacturing / field issues to proactively prevent quality issues
• Deliver presentations to Customers, Service personnel and Sales teams.
• Participation in audits performed by our customers as appropriate
• Bachelors degree in technology, biotechnology, cell biology, biochemistry or equivalent experience (defined as High School Diploma/GED and 4 years progressive experience in a technical field or project management)
• 5+ years project management experience in implementing and equipment validation in a biopharmaceutical production / cGMP environment
• 5+ years project management experience in a biopharmaceutical production / cGMP environment
• An understanding of marketing, sales and support processes, customer needs and have product knowledge
• Ability to work effectively across functions to deliver results and execute multiple commitments within the Global Environment
• Experience with and understanding of the methods of equipment validation in GxP environment
• Strong knowledge of relevant industrial standards such as GAMP5, ASTM E2500, ISPE, ICH
• Multitasking abilities to drive critical issues simultaneously
• Resourcefulness, commitment, interpersonal, communication and negotiation skills
• Excellent verbal and written communication skills in English
• Excellent skills in MS Office products
• Excellent skills in MS Project
• Be based in US, preferable Marlborough, MA and ability to travel within EMEA/USCAN (50%) and globally(15%) to support customer needs
Quality Specific Goals:
• Aware of and comply 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.
• Complete all planned Quality & Compliance training within the defined deadlines.
• Identify and report any quality or compliance concerns and take immediate corrective action as required.
• Ownership of order and configuration quality at the point of entry to ensure accuracy, configuration integrity and that all requirements are tied to documented customer inputs
Additional Eligibility Qualifications
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
• Strong organization, planning and presentation skills
• Service and team oriented
• Strong business sense with an ability to work independently
• Innovative, resourceful and flexible
• A good sense of quality and high energy with the ability to meet all assigned deadlines
• Be able to prioritize and run project with needed rigor to be able to meet delivery dates
• Project Management certifications or equivalent work experience
A little about us:
GE imagination at work.