Location(s): United States ; Massachusetts; Westborough
About Us: GE FlexFactory is a modular, configurable biomanufacturing platform enabling pharmaceutical organizations to quickly attain scalable and cost-efficient manufacturing of monoclonal antibodies, vaccines and other advanced biological drugs. The FlexFactory product reduces operational costs and increases manufacturing flexibility with single-use bioprocessing technology. World-class automation is required to fully leverage benefits of integrated production operations within FlexFactories. 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 Automation Project Leader is accountable for developing solutions and implementing automation projects that are in line with customer requirements and business strategy. The project leader is a focal point and responsible for automation solutions in terms of the features, functionality and quality that GE offers to our customer.
Essential Responsibilities: Essential Responsibilities You will lead development of standard and custom automation platforms working with global, cross-functional development teams . You will be accountable for achieving quality objectives, meeting development schedules, and team effective execution, as well as communicating program status and escalating issues when appropriate to facilitate transparency.
Responsibilities : Leading and managing new automation platform development and customoization.
• Working closely with all cross-functional groups in delivering effective new product development process results • Leading all cross-functional program activities for development and installation of software and/or hardware programs • Ensuring compliance with Design History File (DHF) and other QMS requirements • Managing global program resources, quality objectives, regulatory requirements, schedules, and program risks and making decisions based on business objectives • Together with the Automation Lead Engineer, provide evidence of efficiencies gain by re-use and optimization
Qualifications/Requirements: 1. BS Degree in Computer Science, Mechanical, Electrical Engineering or equivalent 2. At least 6 years of automation project implementation experience 3. Demonstrated leadership of cross-functional project teams and an ability to drive project design plans to completion 4. Familiarity with ISO, FDA and other regulatory standards 5. Demonstrated success in building and leading collaborative global and cross-functional teams and relationships 6. Demonstrated facilitation and negotiation skills in driving closure on product/program-related decisions/issues
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. Drive compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones 5. Identify continuous improvement activities by initiating the implementation of process and product quality improvement initiatives
Desired Characteristics: 1. Strong written and verbal communication skills 2. Experience with conflict resolution 3. 7 years of relevant project leadership experience 4. Experience with life cycle management of standard and custom automation solutions 5. Ability to travel internationally up to 20% of time
Locations: United States ; Massachusetts; Westborough
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