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Sr. Engineer I, Facilities - Analytical Instrumentation

Job in Gastonia, Gaston County, North Carolina, 28054, USA
Listing for: Biogen, Inc.
Full Time position
Listed on 2026-08-17
Job specializations:
  • Engineering
    Systems Engineer, Automation & Mechatronics Engineer, Instrumentation Tech, Quality Engineering
Salary/Wage Range or Industry Benchmark: 93000 - 121000 USD Yearly USD 93000.00 121000.00 YEAR
Job Description & How to Apply Below

About This Role

The Sr. Engineer I, Facilities 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 Data loggers, 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…

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