Sr Automation Engineer II, BMS (Gene Therapy)

Job Description

Biogen is accelerating gene therapies that may one day help transform the way we treat neurological diseases. The Sr Automation Engineer II, BMS (Building Management System) Gene Therapy will be responsible for mechanical system automation (HVAC / Utilities) for the Biogen Gene Therapy Manufacturing Facility.Initially, this role will support the greenfield project and will transition into a site automation role. You will perform function to provide controls / automation technical support, management, and execution of small to medium projects / assignments from initial concept to final closeout. Youwill also communicate findings verbally and in writing while creating mitigating actions to ensure reliability of equipment. You 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.

• Work with site technical and operations personnel to ensure 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.
• 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.), and lead team review of designs and document decisions.
• Maintain systems used in automation and controls systems in direct support of facilities and 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 / 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 ensuring safety, regulatory compliance, company standards, operational requirements and business needs are met.

You have a demonstrated ability to routinely carry out high quality engineering and technology, as indicated by the successful completion of projects. You can initiate deviations, conduct investigations, communicate findings, and provide solutions to cross-functional teams while meeting commitment and due dates.

Qualifications

• Bachelor’s Degree (Electrical, Computer, Chemical Engineering or a related discipline) with a minimum of 8 years of relevant experience, orMBA / Master's Degreewith a minimum of 6 years relevant experience

• Hands on experience with controls equipment including PLCs, HMIs, SCADA systems, and networking equipment
• Experience with controls for mechanical and clean utility systems
• Experience with Rockwell systems including Factory Talk and Historian including programing, testing, and troubleshooting applied to plant utility and HVAC systems, preferably in a GMP industry
• Microsoft Windows – operating systems experience
• Must be willing to participate in an on-call rotation
• Must be willing to work in an open office environment
• Must understands risks and associated controls with working in electrically classified areas

• Experience in gene therapy, biotech, or similar manufacturing environment
• Experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment experience preferable
• Experience with communication protocols including but not limited to RS-485, RS-232, Ethernet, Data Highway Plus, Modbus or Profibus
• Experience writing protocols, test scripts, user requirements, and system design documents
• Allen Bradley experience

Additional Information

Physical demands include ability to use computer applications and to sit majority of the day while executing duties. Must be able to walk between buildings several times a day and be able to stoop and bend as necessary to discharge responsibilities. Some standing throughout the day (1-2 hours) is required as needed.

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.