Lead Engineer, Instrumentation and Controls

2 weeks ago

Triangle Township, United States Biogen Full time
Job Overview

Position Summary

The Senior Engineer II, specializing in Instrumentation and Controls, plays a pivotal role in delivering engineering support and resolving issues related to Manufacturing Process, Utility Equipment, and Laboratory Analytical instrumentation. This position is integral to cross-functional teams aimed at enhancing existing processes and implementing improvements. Collaboration with various departments such as Utilities, Manufacturing, Process Engineering, and Maintenance is essential to optimize asset reliability.

Key Responsibilities

  • Diagnose operational challenges and propose system enhancements.
  • Revise and maintain standards, technical drawings, and specifications.
  • Create validation protocols while providing expertise in equipment and automation design or modifications.
  • Draft deviations, CAPA's, and change control documentation within a GMP framework.
  • Configure Instrumentation & Control (I&C) systems, which encompass utilities, process, and laboratory instrumentation, as well as control system hardware and software.
  • Assist in capital and operational expenditure initiatives, including project scoping, modifications, design evaluations, change controls, construction support, commissioning, and validation.
  • Identify and oversee I&C contractors.
  • Manage lifecycle processes for I&C systems and equipment, driving upgrades and continuous improvements.
  • Provide interim supervision and training for I&C technicians.
  • Act as a representative for the department in cross-functional and global teams to address challenges, implement changes, and enhance processes.
  • Maintain personal training records, development goals, compliance activities, and progress tracking.
  • Offer engineering and validation support for utility systems.
  • Collaborate with other teams as a representative of the facilities engineering division.
  • Complete assigned tasks under the guidance of the Facilities Engineering manager.
  • Mentor and coach junior staff within the Facilities Engineering team.
  • Contribute to achieving milestones associated with specific equipment projects or deliverables.

Candidate Profile

The ideal candidate is a proactive problem-solver with extensive expertise in Instrumentation & Control systems. They possess strong troubleshooting skills, a desire to enhance existing systems, and the ability to develop and update technical documentation. Enjoying collaboration and leadership, they manage contractors effectively and provide mentorship to junior staff. A solid background in Critical Risk Analysis and a proven track record of successful project execution are essential.

Qualifications

  • Bachelor's degree in Electrical, Chemical, Mechanical, or a related engineering discipline.
  • A minimum of 7 years of relevant experience.
  • Practical understanding of FDA GMP and EMA regulations.
  • Prior experience with various control systems and HMIs, including programming and configuration capabilities.
  • Ability to interpret electrical schematics and instrumentation datasheets.
  • Experience with enterprise and IT systems.
  • Excellent verbal and written communication skills.
  • Proficiency in Microsoft Office Suite.
  • Willingness to work extended hours or weekends as needed.

Why Join Biogen?

At Biogen, we are dedicated to fostering a culture of excellence and innovation. As a mid-sized biotechnology firm, we combine the stability of an established organization with an environment that encourages individual contributions. Our team is composed of talented and passionate professionals who have exceptional opportunities for learning and growth. Together, we strive to deliver transformative medicines, with every role being crucial to our mission. We are committed to building an inclusive culture that reflects the diverse communities we serve.

Biogen is an equal opportunity employer, and we value diversity in our workforce. All qualified applicants will receive consideration for employment without regard to any protected status.

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