Coordinate the detailed design and solve any design issues during the design phase and acts as a contract for system design related questions. Participates in developing and updating the FlexFactory project schedule.
Duties include: Support customer meetings by providing system hardware understanding. Develop, explore and recommend manufacturing concepts to fit customer needs/facility requirements. • Assure compliance 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 • Work closely with Customer’s Subject Matter Experts (SMEs) to ensure continuous exchange of critical and technical information needed to execute design activities on time • Complete all planned Quality & Compliance training within defined deadlines • Identify and report any quality or compliance concerns and take immediate corrective action as required • Work closely with Process Design Engineers to ensure that the equipment specification meets customer and process needs, and that equipment layout is optimized for the customer facility. • Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones • Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives • Approximately 10-30% travel depending on project specifics and geographic location
Qualifications/Requirements • BS or MS degree in biochemical / chemical engineering or a related engineering/life Science discipline • Minimum of 5 years of relevant bioprocess experience • Working knowledge of pharmaceutical/biotech processes, equipment hardware, and single use technology • Thorough knowledge of biologics CMC, cGMP manufacturing requirements • Technical understanding of automation systems used in the biopharma (Delta V, PLC, PI, etc.) • Experience in working/leading within cross functional teams • Experience with AutoCAD, Visio, MS Project, SuperPro • Fluent in English both verbally and in writing
Desired Characteristics • Master’s Degree • Disposable technology design and application experience • 2 years of direct experience working in a pilot plant or GMP manufacturing facility • Detail oriented, excellent at critical analysis and problem solving • Experience working in global business environment with sound understanding of global processes • Open to a changing environment • Structured, organized, Analytical, Team oriented