Principal Engineer, Automation

Industry: Pharmaceuticals & Biotech


11 - 15 years

Posted 29 days ago

Principal Engineer, Automation at Boehringer Ingelheim Fremont, Inc in 6701 Kaiser Drive, Fremont, CA 94555.

Job Duties: Deliver and maintain automation-based systems and solutions which provide for flexible, innovative, cost effective, compliant and quality-focused manufacturing of Bio-Pharmaceuticals. Provide Automation support to the daily operations, continuous improvement and capital projects for areas such as Pilot Plant, Bulk Manufacturing (upstream and downstream), Filling, Assembly, Packaging, Utilities, Facilities and other DCS and PLC Automated Equipment and Control Systems on a GMP regulated environment for clinical and commercial production. Interfaces with Manufacturing, Process Science, QA, and Contract Engineering/Vendor firms to develop Designs and Strategy such as: recipe development for new product introductions, Capital Projects definition and strategy, testing/qualification strategy, User Requirements and Functional Requirements Specifications. Perform system administration duties for virtualized systems such as Delta V distributed control systems (DCS), including troubleshooting, preventative and corrective maintenance activities, software patches, and system upgrades. Implement changes to existing control system hardware and software; approve and supervise modifications done by outside vendors and junior engineers; develop, review and/or approve specifications and testing documentation; strategic definition of projects scope, schedule, and cost; successful implementation, testing and release of projects and modifications; and represent the automation discipline during internal and external audits. Lead and Support Capital Projects by developing, planning and implementing automation based projects and solutions in collaboration with cross-functional teams, including determination and delivery on scope, schedule, cost estimation, and quality to ensure the sustained production, successful product launches and customer satisfaction. These projects may be new systems and/or retrofit of existing. Provide project management and technical leadership to projects in support of the BI Capital Plan. Act as a Project Manager for Automation-related projects. Support the qualification strategy definition and successful qualification of automated systems/equipment. Provide documentation, testing, commissioning and validation support following Good Documentation Practices. Provide advanced technical expertise: Perform troubleshooting to the automated equipment. Assist junior resources in troubleshooting; Ensure effective maintenance and availability of automation equipment. Define streamlined preventive/predictive maintenance processes for automated systems. Identify opportunities to increase systems reliability; Execute equipment and control system modifications adhering to Bio-pharmaceutical GMP change control standards, procedures and policies. Support the strategic definition of Change Controls processes and tasks. Support software and hardware life cycle management efforts for control systems such as Delta V DCS to ensure systems remain current and compliant. Perform advanced automation system design that support Data Integrity, stability and interface between different systems. Implement configuration changes to OSI Soft PI Historian when required for equipment/instrumentation/data addition. Investigate and analyze customer opportunities for improvement. Design, recommend and implement improvement suggestions. Support investigation teams for deviation root cause analysis, definition of CAPAs. Create, modify, and maintain automation system documentation, including automation specification documents and SOPs, in a compliant state that includes Safety, GMP and BI policies and procedures.

Job Requirements: Bachelor's degree (US or foreign equivalent) in Computer Science, or Chemical, Mechanical, Computer, or Electrical Engineering, or related field and twelve (12) years of experience in the job offered or related role. In lieu of a Bachelor's degree and twelve (12) years of experience, the employer will accept a Master's degree (US or foreign equivalent) in Computer Science, or Chemical, Mechanical, Computer, or Electrical Engineering, or related field, and ten (10) years of experience in the job offered or related role. Must have eight (8) years of automation experience. Must have six (6) years of GMP experience. Must have five (5) years of project leadership experience. Must also have: Working knowledge of the process equipment, instrumentation, and/or computerized systems typically applied to Bio-pharmaceutical manufacturing processes; Technical writing and presentation skills; Analytical skills to identify potential improvement opportunities, and drive to opportunities to realization; Ability to lead multidisciplinary project groups and deal with customers and suppliers; Understanding of legal and regulatory aspects within Bio-pharmaceutical business such as Quality Compliance and Environmental, Health and Safety (EHS); experience in working independently on continuous improvement and driving processes and systems to agility and simplicity, while maintaining Safe and Quality Compliant systems/processes; and experience in the design, configuration, support and testing of Delta V DCS and OSI Soft PI.

Work Schedule: 40 hours per week (8:00am to 5:00pm)