Sr. Manufacturing Automation Engineer II in La Verne, CA

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Pharmaceuticals & Biotech   •  

8 - 10 years

Posted 7 weeks ago

Job Description

Sr. Manufacturing Automation Engineer II

Job Responsibilities:

  • Maintain the automation servers, systems and network devices for process equipment and systems
  • Develop and implement strategies for data management and data flow through automation network.
  • Locate and diagnose system failures and perform troubleshooting for automated process equipment and systems
  • Develop solutions to automate manual tasks by implementing upgrades to PLCs, HMIs and SCADA systems
  • Support the high levels of reliability for the Process Control System Information Management and Network Infrastructure
  • Manage the standards, methods and procedures for the design, modification, and maintenance of manufacturing processes.
  • Develop, modify and redline specifications for: mechanical and electrical contractors, equipment, software, hardware, P&ID, network topology, PFD, wiring diagrams, panel drawings, etc.
  • Plans, executes and tracks a variety of engineering projects.
  • Contributes to the development of department strategy.
  • Coordinates cross-functional efforts to resolve manufacturing and maintenance issues in projects and day-to-day operational activities.
  • May participate in audits to include internal, vendors or contract manufacturers.
  • Implements systems for tracking project progress.
  • Supports and contributes to site continuous improvement initiatives.
  • Compiles and reports technical performance metrics.
  • Maintains and develops existing engineering systems which support equipment run times.
  • Develops lifecycle documents including URS, FDS, SDS, FAT, SAT, Commissioning, IQ, OQ, and PQ protocols.

Knowledge and Skills:

  • Demonstrates extensive understanding and application of process engineering principles, concepts, practices, and standards.
  • Demonstrates proficiency in current Good Manufacturing Practices (GMPs), 21 CFR Part 11/Annex 11, regulatory compliance, strategic planning, data management, and safety regulations.
  • Demonstrates knowledge of pharmaceutical process manufacturing, OEE, MTBF, and root cause failure analysis.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.
  • Proficient in Microsoft Office applications

Education and Experience:

  • 7+ years of relevant experience, and a BS or BA or related fields.
  • 5+ years of relevant experience, and a MA or MBA.
  • Has experience with automated infrastructure that include: security strategies, network architecture, platform selection and full implementation of 21 CFR Part 11 and EU annex 11 requirements
  • Has extensive experience in PLC-based programming (e.g. Rockwell software)
  • Has previous experience with developing Audit, Event, and Batch reports and integrated into centralized reporting system.
  • Has previous experience in biotech or pharmaceuticals industry.
  • Has previous experience in engineering in highly-regulated manufacturing environments.