Location(s): United States; Massachusetts; Marlborough
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: Responsible for technical leadership of the project software configuration. The Automation Lead Project Engineer co-ordinates the work of the Project engineers in producing the software configuration.
Essential Responsibilities: Responsibilities : • Interface with clients to manage requirements • Resolve technical questions and concerns through interaction with customers, vendors and internal personnel • Review of detail design (Functional Design Specification & Software Design Specification) documents to ensure alignment with agreed approach and Functional Specifications • Review of code to ensure quality and requirements are met • Review of software testing documents from vendor to ensure alignment with agreed approach and FDS/SDS documents • Witness the execution of the design testing (DT) and configuration testing (CT) and ensure they meet quality guidelines • Perform documentation updates with the GE quality systems • Participate in commissioning and qualification activities
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. Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables. 5. Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives.
Qualifications/Requirements: 1. Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Industrial Engineering, or related field. Other degrees considered if combined with 5+ years’ experience in process equipment project implementation. 2. Knowledge of governing regulations, specifically 21CFR211 and Eudralex Volume 4 Annex 11. 3. Understanding and experience with cGMP Change Control systems as well as Good Documentation Practices. 4. Working knowledge of SDLC (GAMP). 5. Previous project or team experience.
Desired Characteristics: 1. Knowledge of quality systems within bioprocess manufacturing 2. Ability to write reports and procedure manuals, and to effectively present information and respond to questions from managers and engineers. 3. Knowledge of quality systems within bioprocess manufacturing 4. Experience with SCADA and PLC 5. Knowledge of FDA, MDD, IEC, and ISO regulations and guidelines.
Locations: United States; Massachusetts; Marlborough
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