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Job Details


Biogen

Sr Engineer I, Automation

Life, Physical, and Social Science

All

Yearly

Full Time

No

Research Triangle Park, North Carolina, United States

Job Description About This Role The Sr. Automation Engineer I will expected to prioritize, plan and execute multiple projects independently and will be performing function to provide controls/automation technical support, management and execution of small to medium projects/assignments from initial concept to final closeout. What You’ll Do The Sr. Automation Engineer I will have the ability to prioritize, plan and execute multiple projects independently and will be performing function to provide controls/automation technical support, management and execution of small to medium projects/assignments from initial concept to final closeout. You will initiate deviations, conduct investigations, communicate findings, and provide solutions to cross functional teams while meeting commitment and due dates. The position will communicate findings verbally and in writing while creating mitigating actions to ensure reliability of equipment. The Sr. Automation Engineer I must be able to monitor, repair, troubleshoot and create solutions to manufacturing and utilities system failures and provide technical support to other technical leaders and technicians. Additional responsibilities of the Automation Engineer include: Work with site technical and operations personnel to ensure that business needs and regulatory requirements are met by the control systems supplied. Perform a lead role with site technical departments to develop standards for control systems and instrumentation for new and existing equipment. Responsible for maintaining systems used in automation and controls systems in direct support of operations. Troubleshoot site controls systems programming logic & make changes utilizing site change management if required. Provide timely resolution and troubleshooting of technical issues related to automation control systems. Support off shift operations by being part of on call rotation. Provide high-level 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. Concurrently manage and execute or participate as a team member on multi-disciplined automation and controls capital and 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. Prepare project estimates for control/automation design, equipment, installation, labor, materials, and other related costs. Prepare project forecasts and schedules and tracks costs. Ensure selection of new control system equipment and instrumentation for capital projects assuring meet all regulatory requirements and all instrumentation is correct for the intended use. Demonstrate ability to routinely carry out high quality engineering and technology, as indicated by the successful completion of projects. Specify, design and install control systems in direct support of commercial and clinical manufacturing operations. Manage, coordinate and oversee development of project design documents. Select A&E firms to perform engineering design. Coordinate and review work of all designs and deliverables (drawings, specifications, etc.). Lead team review of designs and document decisions. Responsible for the design of new applications. Lead project teams or a team focused on a discreet topic. Who You Are You have strong technical knowledge and experience with controls equipment, electronic batch records and networking equipment from a pharmaceutical environment. As a person you are solutions oriented and not afraid to challenging the status quo. Qualifications University degree or the equivalent combination of education and experience required (Electrical, Computer, Chemical Engineering or a related discipline). Minimum 10 years hands on experience with controls equipment including Rockwell PLCs and HMIs, Wonderware SCADA system, SQL relational database systems, electronic batch records and networking equipment. Pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment experience required . In addition to Wonderware and Rockwell required experience, Siemens experience is preferable. Microsoft Windows – operating systems experience. Communication protocols including but not limited to RS-485, RS-232, Ethernet, Data Highway Plus, Modbus or Profibus experience preferable. Writing protocols, test scripts, user requirements, and system design documents experience preferable. Strong organization, interpersonal, oral and written communication skills. Must be able to prioritize multiple commitments and technical problems. Must be willing to participate in an on-call rotation. Understands risks and associated controls with working in electrically classified areas. Additional Information Why Biogen? Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.