Instrumentation and Controls Senior Engineer

2 weeks ago

Triangle Township, United States Biogen Full time
Job Overview

Position Summary

The Senior Engineer II, specializing in Instrumentation and Controls, is responsible for providing technical engineering support and resolving issues related to Manufacturing Process, Utility Equipment, and Laboratory Analytical instrumentation. This role involves collaboration with cross-functional teams to implement enhancements and optimize existing processes. The position works closely with various departments, including Utilities, Manufacturing, Process Engineering, and Maintenance, to assess, target, and enhance the reliability of all assets.

Key Responsibilities

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

Candidate Profile

The ideal candidate is a proactive problem-solver with extensive experience in Instrumentation & Control systems. They possess strong troubleshooting skills, a desire to enhance existing systems, and the ability to develop and update technical documentation. The candidate enjoys leading and collaborating with cross-functional teams, managing contractors, and mentoring junior staff. Expertise in Critical Risk Analysis and a proven track record of successful project delivery 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, along with the capability to program/configure these systems.
  • Ability to interpret electrical drawings and instrumentation datasheets/schematics.
  • Experience with enterprise/IT systems.
  • Excellent oral and written communication skills.
  • Proficiency in Microsoft Office Suite.
  • Willingness to work extended shifts or weekends if required.

Why Join Biogen?

At Biogen, we are a global team dedicated to excellence and innovation. As a mid-sized biotechnology company, we offer the stability and resources of an established organization while promoting an environment where individual contributions are valued. Our team consists of talented and passionate professionals who have exceptional opportunities for learning, growth, and skill enhancement. Together, we strive to deliver life-changing medicines, with every role being crucial to our mission. We are committed to fostering a culture of inclusion and belonging that reflects the diverse communities we serve.

Biogen is an E-Verify Employer in the United States.

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