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North Carolina, United States
Onsite
About This Role
The Sr. Engineer I, Instrumentation & Controls serves as a technical expert for analytical instrumentation and instrumentation & controls (I&C) systems supporting pharmaceutical manufacturing and laboratory operations. This role partners across Engineering, Manufacturing, Maintenance, Technical Development, and Manufacturing Sciences to improve equipment reliability, compliance, and operational performance. The engineer will lead troubleshooting efforts, support capital and maintenance projects, oversee commissioning and qualification activities, and drive continuous improvement initiatives across critical facility and manufacturing systems.
What You'll Do
Provide engineering and validation support and troubleshooting for Manufacturing Process and Laboratory Analytical Instrumentation including the following systems:
Cytiva Filter Integrity Testers, Vi-Cell Blu Cell Counter, Kaye AVS, Lives Temperature and Humidity Dataloggers, Climet Particle Counters, Osmotech XT osmometer, Metler Toledo pH probes (LabX)
Author deviations, CAPAs, and change control records in a GMP environment related to analytical instrumentation used throughout the manufacturing site
Support in-house and vendor calibrations of analytical instruments and managed scheduling in CMMS
Subject Matter Expert in Critical Risk Analysis and System Impact Analysis for analytical instrumentation
Support instrumentation related capital and op-ex projects, including scoping, modifications, design reviews, change controls, and validation
Develop and maintain site standards for instrumentation, controls, calibration, and metrology systems.
Bridge automation and metrology functions by implementing effective equipment control strategies and calibration programs.
Lead instrumentation and controls projects from design through implementation while managing scope, schedules, resources, and budgets.
Support commissioning, qualification, and startup activities for new equipment and facility upgrades.
Utilize and troubleshoot multiple control platforms including Empower, LabX, Siemens Poccelerator, Finesse, DeltaV, PLCs, SCADA, DCS, DAS, and LIMS systems.
Partner with cross-functional teams to identify opportunities for process improvements and operational excellence.
Mentor I&C technicians and junior engineers to strengthen technical capabilities across the organization.
Support regulatory inspections and audits by providing technical expertise and defending engineering practices and procedures.
Who You Are
You are a hands-on engineering professional with deep expertise in analytical instrumentation and controls systems who enjoys solving complex technical challenges. You thrive in collaborative environments, take ownership of critical projects, and are motivated by improving system reliability, compliance, and operational performance. You bring strong technical judgment, excellent communication skills, and a continuous improvement mindset to every project you support.
Required Skills
Bachelor's degree in Engineering.
4 years of relevant engineering experience in pharmaceutical, biotechnology, manufacturing, or highly regulated environments.
Strong knowledge of FDA GMP and EMA regulatory requirements.
Expertise with analytical instrumentation including HPLC, UPLC, pH/conductivity instrumentation, balances, and scales.
Experience supporting pharmaceutical manufacturing and laboratory instrumentation systems.
Proficiency configuring and troubleshooting instrumentation and control systems, including DeltaV, PLCs, DCS, SCADA, DAS, LIMS, and laboratory instrumentation software.
Ability to interpret and troubleshoot control panel wiring diagrams and electrical schematics.
Experience authoring and executing validation protocols, deviations, CAPAs, and change controls.
Strong project leadership and cross-functional collaboration skills.
Excellent written and verbal communication skills.
Proficiency with Microsoft Office Suite, SharePoint, and Microsoft Project.
Ability to support occasional extended shifts or weekend work as business needs require.
Preferred Skills
Experience with low-voltage control panel wiring, troubleshooting, and repair.
Additional expertise with facility and utility instrumentation systems.
Experience supporting regulatory inspections and defending engineering practices to health authorities.
Experience in GMP biotechnology or pharmaceutical manufacturing environments.
Validation and commissioning experience for manufacturing and facility systems.
Experience leading capital projects and implementing instrumentation upgrades.
Demonstrated ability to mentor technicians and junior engineers.
Continuous improvement, reliability engineering, or asset management experience.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
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 Biogen.
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.
