The Sr. Engineer II, Automation provides 24/7 process controls/automation technical site support to the Biogen 900 Davis drive, NC manufacturing site. In addition, this role manages multiple small OPEX/CAPEX projects and continuous improvement initiatives that support the site from initial conception to final closure. The Sr Engineer II, Automation prioritizes between supporting the site and managing their assigned projects and tasks.
What you'll do
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 cGMP (current Good Manufacturing Practice) 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.
Who You Are
A self- starter and self-motivated individual who drives results and leads change. You are very organized and thrive working in a dynamic environment where strong technical knowledge and execution are required.
Qualifications
Bachelors Degree (Electrical, Computer, Chemical, Mechanical Engineering or a related engineering discipline).
Minimum 6-8 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.
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
