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Automation Engineer I

2 months ago

Triangle Township, United States Biogen Full time
About This Role

The Senior Automation Engineer I provides 24/7 process control technical site support to the Biogen manufacturing site. In addition, this role manages multiple small operating expense and capital projects and continuous improvement initiatives that support the site from initial conception to final closure.

Key Responsibilities
  • System Design and Implementation
    • Specify, design, develop, install, commission, and qualify process control and automation solutions in direct support of commercial and clinical manufacturing operations.
    • Collaborate with cross-functional teams to understand process requirements and develop control system specifications.
    • Configure and program Supervisory Control and Data Acquisition (SCADA), Programmable Logic Controllers (PLC), and Human-Machine Interface (HMI) systems.
  • Instrumentation and Control System Integration
    • Specify and select appropriate instrumentation for process monitoring and control.
    • Integrate various control systems and devices to ensure seamless communication and coordination.
    • Troubleshoot and resolve issues related to control system integration.
  • Validation and Compliance
    • Ensure all automation systems comply with regulatory requirements, including current Good Manufacturing Practice (cGMP) standards.
    • Participate in validation activities, including writing and executing validation protocols.
    • Maintain documentation in accordance with industry and company standards.
    • Provide technical assistance to site quality systems through investigations, control system assessments, and corrective/preventative support to ensure a compliant GMP workplace.
    • Work with the Site Quality units to ensure deviations and CAPAs are completed ensuring due dates are met in a timely manner.
  • Continuous Improvement
    • Identify opportunities for process optimization, reliability improvement, and cost reduction through automation.
    • Implement changes to enhance system performance and reliability.
    • Stay abreast of industry trends and emerging technologies to recommend improvements.
  • Troubleshooting and Maintenance
    • Provide technical support diagnosing and resolving automation systems issues in a timely manner.
    • Develop and implement preventive maintenance procedures for control systems.
    • Participate in on-call rotation for technical issues.
    • Possible night shift support when/if needed in the future.
  • Collaboration and Communication
    • Collaborate with cross-functional teams, including process engineers, validation specialists, and maintenance teams.
    • Provide training to operations and maintenance personnel on control system functionalities.
  • Operating Expense and Small Capital Projects Support
    • Prepare project estimates for control/automation design, equipment, installation, labor, materials, and other related costs. Prepare project forecasts and schedules and tracks costs.
    • Concurrently manage and execute or participate as a team member on multi-disciplined automation and controls capital and operating expense projects from inception to project completion in support of site operations insuring safety, regulatory compliance, company standards, operational requirements and business needs are met.
    • Ensure selection of new control system equipment and instrumentation assuring it meets all regulatory requirements and all instrumentation is correct for the intended use.
    • Perform a lead role with site technical departments to develop standards for control systems and instrumentation for new and existing equipment.
Requirements
  • Bachelor's Degree in Electrical, Computer, Chemical, Mechanical Engineering or a related discipline.
  • Minimum 4-6 years hands-on experience in process control/automation, preferably in the pharmaceutical industry.
  • Experience with Rockwell PLCs and HMIs, Wonderware System Platform/Archestra, SQL databases management, Networking and Communication protocols, Microsoft Server configuration and administration.
  • Experience with validation processes and documentation: Writing user requirements, system functional/design documents, and test protocols experience.
  • Must be willing to participate in an on-call rotation and possible shift coverage.
  • Understands risks and associated controls with working in electrically classified areas.
Preferred Qualifications
  • Siemens PLCs and HMIs experience is a plus.
  • Manufacturing Execution Systems experience is a plus.
  • Pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment experience.