Senior Facilities Instrumentation Engineer - I&C & GMP Expert

Biogen; Milwaukee (WI); On-site; USD 93,000 - 121,000; Full time

Benefits offered by this job

Health benefits

Wellness programs

Paid vacation

Holidays

Sick time

Parental leave

401(k) match

Employee stock purchase plan

Tuition reimbursement

ERG participation

Job summary

Biogen in Milwaukee is seeking a Sr. Engineer I, Facilities to serve as a technical expert for analytical instrumentation and I&C systems supporting pharmaceutical manufacturing and labs.

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

Qualifications

• Bachelor's degree in Engineering.
• 4 years of engineering experience in pharmaceutical, biotechnology, manufacturing, or 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.

Responsibilities

• 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.

Skills

Analytical instrumentation

I&C systems

DeltaV/PLCs/DCS/SCADA

HPLC/UPLC

Equipment calibration

Validation protocols

Cross-functional leadership

MS Office/SharePoint

Reading wiring diagrams

Weekend/extended shifts

Education

Bachelor's degree in Engineering

Tools

LIMS

DAS

Job description

Biogen in Milwaukee is seeking a Sr. Engineer I, Facilities to serve as a technical expert for analytical instrumentation and I&C systems supporting pharmaceutical manufacturing and labs.

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