Senior I&C Engineer — Pharma Instrumentation & Controls

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

Benefits offered by this job

Medical insurance

Dentist & Vision coverage

Tuition reimbursement

401(k) with match

Stock purchase plan

Job summary

Biogen is seeking a Sr. Engineer I in Instrumentation & Controls to act as a technical expert for analytical instrumentation used in pharmaceutical manufacturing and labs.

You will partner across engineering, manufacturing, and QA to improve reliability, compliance, and performance. You will lead troubleshooting, support capital and maintenance projects, and drive commissioning, qualification, and validation activities across critical systems.

Qualifications

• 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.

Responsibilities

• Provide engineering and validation support for Manufacturing Process and Laboratory Instrumentation.
• Lead troubleshooting for analytical instrumentation across the site.
• Author deviations, CAPAs, and change controls in GMP environments.
• Support calibrations and CMMS scheduling for analytical instruments.
• Serve as SME in Risk Analysis and System Impact Analysis for instrumentation.
• Lead instrumentation capital and op-ex projects from scope to validation.
• Develop and maintain site standards for instrumentation, calibration, and metrology.
• Bridge automation and metrology functions with calibration programs.
• Mentor I&C technicians and junior engineers.
• Support regulatory inspections with engineering expertise.

Skills

Instrumentation systems

Regulatory knowledge GMP/EMA

Project leadership

Communication skills

Microsoft Office

Troubleshooting & calibration

Education

Bachelor's degree in Engineering

Tools

DeltaV

PLCs

DCS

SCADA

DAS

LIMS

Lab instrumentation software

Job description

Biogen is seeking a Sr. Engineer I in Instrumentation & Controls to act as a technical expert for analytical instrumentation used in pharmaceutical manufacturing and labs.

You will partner across engineering, manufacturing, and QA to improve reliability, compliance, and performance. You will lead troubleshooting, support capital and maintenance projects, and drive commissioning, qualification, and validation activities across critical systems.