September 15
🇺🇸 United States – Remote
💵 $208.8k - $243.6k / year
⏰ Full Time
🟡 Mid-level
🟠 Senior
👷♀️ Project Manager
• Manage and direct project teams with responsibility for multiple automation projects • Responsible for delivery of Automation scope under CAPEX projects • General management and oversight of the software documentation effort • Supervision and management of external engineering contractors and software/hardware vendors • Coordinate and manage project activities to meet scope, schedule, budget, safety, and quality requirements • Responsible for all controlled engineering documentation throughout the project lifecycle • Project Close-out activities involving completion of technical close-out reports and summary of assets • Develop and continuous improvement of technical global standard for electronic batch recording • Ongoing development of site automation strategy that delivers the site goals and objectives
• Bachelor's Degree in Bioengineering or equivalent experience • Master's degree in science preferred • Extensive experience in project management and coordination associated with the execution of capital projects in an industrial environment • Extensive experience with design and operation of Biopharmaceutical facilities, both manufacturing and support systems (cGMP manufacturing, pilot plant & laboratories) • Extensive experience with control systems (PLC, DCS, MES) desirable • Extensive practical experience in the management and coordination of engineering & construction management consultants, equipment vendors and contractors • Capacity to deliver strong and effective project engineering skills on capital projects • Strong understanding of the fundamentals of large-scale commercial mammalian cell culture processing and aseptic filling • Understanding of the latest ASME Bioprocess Equipment standard including sanitary design of equipment/piping systems and design for Cleaning in place (CIP) and Sterilization in place (SIP) design and operation • Experience with design and operation of large-scale Process Control Systems (PCS) and/or SCADA/PLC based automation systems • Experience with historians, preferably OSISoft PI • Experience with design and operation of Manufacturing Execution Systems (MES) • Experience with MES integration with Enterprise Resource Planning (ERP) systems, preferably SAP • Experience with design of PCS, MES and associated Network Architecture System hardware design for PCS and MES • Experience with virtualization infrastructure and design • Travel <25%
• Performance-related bonus • Medical and dental coverage • 401k plan • Life insurance • Short-term and long-term disability insurance • Employee assistance program • Paid time off (PTO) • More
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