yoinka

Sr. Engineer I, Facilities

Biogen

Research Triangle Park, NCSeniorH-1B sponsor company
Sign in to applyVerified 2h ago
Location
Research Triangle Park, NC
Work model
On-Site
Level
Senior
H-1B history
30 approvals (FY2023)
Posted
1d ago

About this role

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

Serve as the site subject matter expert for analytical instrumentation and control systems supporting manufacturing and laboratory operations. Specify, install, commission, qualify, and maintain analytical instrumentation and associated control systems. Troubleshoot equipment and instrumentation issues to improve reliability, compliance, and operational efficiency. 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. Author and execute validation protocols, change controls, deviations, CAPAs, and other GMP documentation. 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

Sr. Engineer I, Facilities at Biogen — Research Triangle Park, NC | Yoinka