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 the timely execution of the project in its entirety, from the project kick-off until project completion.
Essential Responsibilities: Responsibilities : • Automation project lead for integrated capital equipment programs • Work with engineering companies to review and approve detailed design • Develop, manage and maintain detailed schedule for automation activities • Interface with clients, vendors, and internal teams to coordinate project schedules and plans • Provide status updates to internal leadership and client team • Manage the resources responsible for configuration and testing of the software components • Manage deliverables from support teams and automation hardware vendor • Lead the coordination of commissioning of GE and third party process equipment
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. 2. Minimum of 10 years experience project managing capital equipment projects 3. Experience with testing and validation of process equipment software 4. Understanding and experience with cGMP Change Control systems as well as Good Documentation Practices. 5. Strong interpersonal skills, including good technical communication. 6. 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 Emerson DeltaV projects or other Distributed Control Systems 5. Experience with PLC and SCADA solutions 6. Experience with MES/ERP platforms, projects and solutions 7. Knowledge of FDA, MDD, IEC, and ISO regulations and guidelines.
Locations: United States; Massachusetts; Marlborough
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