Sr. Engineer I, Facilities
Biogen•Research Triangle Park, NC
•Onsite
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
- 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
