Location(s): United States; Illinois; Arlington Heights
About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry. 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: Provide technical leadership for the production team. Responsibilities include providing documentation and floor support associated with safety, manufacturing and quality methods, tooling, and equipment. Aggressively initiate new processes and methods that will improve safety, reduce product cost and/or improve product quality.
• Drive improved product quality by identifying manufacturing issues, developing cost-effective solutions, and overseeing successful implementation into production. • Work with Production Associates to resolve manufacturing and quality problems related to methods, processes, tooling, equipment and product design. • Ensuring regulatory compliance through Validation & Verification. Responsible for determining processes requiring validation, development of plans and analysis criteria, execution and final analysis and acceptance. • Monitor and improve productivity, while ensuring all customer commitments are met in a timely, quality and cost-conscious manner • Provide Technical support: Develop expertise and fluency in the chemistry of our products and processes in order to (1) Lead IR/CAPA/QMS initiatives; and (2) troubleshoot and contribute to product & manufacturing process improvements from cyclotron operations to final product formulation • Specify and expedite planned maintenance routines on all production equipment and systems • Co-ordination of manufacturing releases • Lead Compliance, as well as Environmental, Health & Safety efforts in support of plant goals • Driving LEAN manufacturing implementation • Provide safe processes that comply with all local and federal regulations. Assure that corrective action is taken to resolve observed safety concerns in all areas. • Learn/comprehend our product histories, filling requirements, and cyclotron theory • Optimize isotope recovery operations, understand IT infrastructure & interdependencies, correlation between non-GMP cyclotron operation, and QMS requirements.
Quality Specific Goals: 1. 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 2. Complete all planned Quality & Compliance training within the defined deadlines 3. Identify and report any quality or compliance concerns and take immediate corrective action as required 4. Knowledge and understanding of document control, design transfer, verification, validation, acceptance activity, DMR, DHR and electronic signature requirements to ensure that product, equipment, tools, processes, software, training and documentation meet requirements.
Qualifications/Requirements: • B.S. Degree in Chemical Engineering or related physics/ technical degree and 3 years’ experience • Understanding of IT QA and testing procedures • Good analytical and planning skills
Desired Characteristics: Preferred Qualifications: 1. M.S. Degree in Engineering or Business 2. Demonstrated ability to identify & implement best practices. 3. Demonstrated ability to perform with high levels of ambiguity 4. Previous Project Experience 5. OMLP Graduate 6. BB or MBB Certified
Locations: United States; Illinois; Arlington Heights
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