Sr Engineer II, Instrumentation & Controls

Biogen - Durham, NC

Full-time - Mid Level

Durham, NC

501-1,000 employees

Chemical Manufacturing

About the position

The Sr. Engineer II, Instrumentation and Controls provides essential engineering technical support and troubleshooting for Manufacturing Process and Utility Equipment, as well as Laboratory Analytical instrumentation. This role is pivotal in participating in multi-functional teams aimed at implementing changes and enhancing existing processes. The position requires collaboration with various teams, including Utilities, Manufacturing, Process Engineering, and Maintenance, to measure, target, and improve the reliability of all assets. The engineer will support the design, specification, installation, commissioning, and qualification of new equipment, which includes writing and executing User Requirement Specifications (URS) and protocols. Additionally, this role involves supporting the technical development of Instrumentation & Control (I&C) Maintenance Technicians and junior engineers, ensuring they are equipped with the necessary skills and knowledge. The responsibilities of this position include troubleshooting site operation issues and identifying system improvements, updating standards, drawings, and specifications, and developing validation protocols. The engineer will provide expertise in equipment and automation design and modifications, author deviations, Corrective and Preventive Actions (CAPAs), and change control records in a Good Manufacturing Practice (GMP) environment. Furthermore, the role involves configuring I&C systems, which encompass utilities, process and laboratory instrumentation, as well as control system hardware and software. The engineer will also support capital and operational expenditure projects, which include scoping, modifications, design reviews, change controls, construction support, commissioning, and validation. Sourcing and supervising I&C contractors, overseeing lifecycle management for I&C systems and equipment, and implementing upgrades and continuous improvements are also key aspects of this role. In addition to these technical responsibilities, the engineer will provide interim supervision and training of I&C technicians, represent the department in cross-functional and global teams to address issues, implement changes, and improve processes. Maintaining personal training, goal development and completion, compliance workflow activities, and progress tracking are also part of the job. The engineer will provide engineering and validation support for utility systems and collaborate with other groups as a representative of the facilities engineering team, completing work tasks under the oversight of the Facilities Engineering manager. Coaching and mentoring junior Facilities Engineering staff and contributing to the completion of milestones associated with specific equipment projects or deliverables are also expected.

Responsibilities

• Troubleshoot site operation issues and identify system improvements.
• Update standards, drawings, and specifications.
• Develop validation protocols and provide expertise in equipment and automation design/modifications.
• Author deviations, CAPA's, and change control records in a GMP environment.
• Configure Instrumentation & Control (I&C) systems, including utilities, process and laboratory instrumentation, control system hardware, and software.
• Support capital and operational expenditure projects, including scoping, modifications, design reviews, change controls, construction support, commissioning, and validation.
• Source and supervise I&C contractors.
• Oversee lifecycle management for I&C systems and equipment, implement upgrades and continuous improvements.
• Provide interim supervision and training of I&C technicians.
• Represent the department in cross-functional/global teams to address issues, implement change, and improve processes.
• Maintain personal training, goal development/completion, investigations, compliance workflow activities, and progress tracking.
• Provide engineering and validation support for utility systems.
• Collaborate with other groups as a representative of the facilities engineering team.
• Complete work tasks with oversight from the Facilities Engineering manager.
• Coach and mentor junior Facilities Engineering staff.
• Contribute to the completion of milestones associated with specific equipment projects or deliverables.

Requirements

• BS in Electrical, Chemical, Mechanical or related engineering field.
• 7 years transferrable experience.
• Practical knowledge of the application of FDA GMP and EMA regulations.
• Prior experience with a variety of control systems & HMI's and the ability to program/configure these systems.
• Ability to read and understand electrical drawings and instrumentation datasheets/schematics.
• Experience with enterprise/IT systems.
• Demonstrates excellent oral and written communication skills.
• Competency in Microsoft Office Suite.

Nice-to-haves

• May be asked to work extended shifts or weekends.

Benefits

• Opportunities for learning and growth.
• A commitment to building a culture of inclusion and belonging.
• A pioneering spirit in a mid-sized biotechnology company.
• Stability and resources of a well-established business.