Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
The Senior Automation Engineer must have proven ability to prioritize, plan and execute multiple projects independently and must perform function to provide controls/automation technical support, management and execution of small to large projects/assignments from initial concept to final closeout. The Senior Automation Engineer 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 Senior Automation Engineer 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 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.
2. 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.
3. 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.
4. 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.
* Minimum 10 years hands on experience with controls equipment including PLCs, HMIs, SCADA systems, SQL relational database systems, electronic batch records and networking equipment.
* Minimum 5 years of experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11 and supporting validation of control system equipment.
* Experience with Wonderware, Rockwell, Siemens, Syncade preferable
* Must have experience with Windows Servers hardware and Microsoft Windows - applications.
* Must have experience with communication protocols including but not limited to RS-485, RS-232, Ethernet, Data Highway Plus, Modbus & Profibus.
* Experience in Oral Solid Dose and/or Parenteral manufacturing preferable
* Must have experience with writing protocols, test scripts, user requirements, and system design documents.
* Must have strong organization, interpersonal, oral and written communication skills.
* Must be able to prioritize multiple commitments and technical problems.
* Must have the ability to shift priorities according to changes in department/facility needs and be open to different ideas/approaches.
* Must be willing to work in an open office environment.
Physical demands include ability to use computer applications and to sit majority of the day while executing duties. Also 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.
Bachelor’s Degree (Electrical, Computer, Chemical Engineering or a related discipline) is required with a MBA/MS Preferred
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