Sr. Engineer I, Facilities - Analytical Instrumentation

Biogen•Research Triangle Park, NC

8d•$93,000 - $121,000

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation