Senior Facilities & Instrumentation Engineer — GMP Compliance

NCBiotech; North Carolina; On-site; USD 93,000 - 121,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with match

Stock purchase plan

Job summary

Biogen is seeking a Sr. Engineer I, Facilities to act as the technical expert for analytical instrumentation and automation systems supporting manufacturing and labs. You will lead commissioning, qualification, and CAPA activities while partnering across engineering and operations.

You will specify and maintain instrumentation, troubleshoot issues, and drive continuous improvement in facility systems, ensuring compliance and reliability in a regulated environment.

Qualifications

• Bachelor's degree in Engineering is required.
• 4 years of engineering experience in regulated environments (pharma/biotech).
• Strong knowledge of FDA GMP and EMA requirements.
• Experience with analytical instrumentation (HPLC/UPLC, pH/conductivity).
• Experience with instrumentation controls systems (DeltaV, PLCs, DCS, SCADA, LIMS).
• Ability to author validation docs, deviations, CAPAs, change controls.

Responsibilities

• Serve as site SME for analytical instrumentation and I&C systems.
• Specify, install, commission, qualify, and maintain instrumentation and control systems.
• Troubleshoot equipment to improve reliability and compliance.
• Develop site standards for instrumentation, calibration, and metrology.

Skills

Analytical instrumentation

Regulatory compliance

GMP knowledge

DeltaV

PLCs/DCS/SCADA

LIMS familiarity

Education

Bachelor's degree in Engineering

Tools

Empower

LabX

Siemens Poccelerator

Finesse

DAS

Job description

Biogen is seeking a Sr. Engineer I, Facilities to act as the technical expert for analytical instrumentation and automation systems supporting manufacturing and labs. You will lead commissioning, qualification, and CAPA activities while partnering across engineering and operations.

You will specify and maintain instrumentation, troubleshoot issues, and drive continuous improvement in facility systems, ensuring compliance and reliability in a regulated environment.