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Senior Instrumentation Engineer
2 months ago
Position Summary
The Senior Engineer II, Instrumentation and Controls plays a crucial role in providing technical engineering support and troubleshooting for manufacturing processes, utility equipment, and laboratory analytical instruments. This position collaborates with cross-functional teams to implement enhancements and optimize existing workflows. The role involves close partnership 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, technical drawings, and specifications.
- Create validation protocols and offer expertise in the design and modification of equipment and automation systems.
- Draft deviations, CAPA documentation, and change control records 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 projects, including project scoping, modifications, design reviews, 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 improvement initiatives.
- 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, goal development, compliance activities, and progress tracking.
- Deliver 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 related to specific equipment projects or deliverables.
Candidate Profile
The ideal candidate is a proactive problem-solver with extensive experience in Instrumentation & Control systems. You possess strong troubleshooting skills, a desire to enhance existing systems, and the ability to develop and update technical documentation. You thrive in collaborative environments, managing contractors, and mentoring junior team members. Your expertise in Critical Risk Analysis and proven track record of successful project execution will be invaluable.
Qualifications
- Bachelor's degree in Electrical, Chemical, Mechanical, or a related engineering discipline.
- A minimum of 7 years of relevant experience.
- Solid understanding of FDA GMP and EMA regulations.
- Prior experience with various control systems and HMIs, along with the capability to program and configure these systems.
- 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 inclusion and belonging that reflects the diverse communities we serve. We believe that diverse backgrounds, cultures, and perspectives strengthen our organization and drive innovation. Our global team is committed to excellence and has the opportunity to make a significant impact in the biotechnology field. Together, we strive to deliver life-changing medicines, with every role contributing to our mission.
We are an equal opportunity employer and welcome applications from all qualified individuals, regardless of 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 law.
