Engineer III, Analytical Instrumentation

Role Summary

Engineer III, Analytical Instrumentation – This role focuses on ensuring critical laboratory systems operate flawlessly across Quality Control and Technical Research. You will lead instrument lifecycle management, troubleshoot complex technical issues, and support compliance and scientific progress in a regulated environment. Based in Durham, NC.

Responsibilities

• Serve as subject matter expert and system owner for assigned laboratory instrumentation, ensuring compliance and optimal performance.
• Oversee qualification and lifecycle management of new and existing instruments to maintain validated state and regulatory standards.
• Investigate instrumentation deviations thoroughly and implement robust corrective actions to prevent recurrence and improve reliability.
• Manage change control processes for qualified systems and laboratory modifications, ensuring documentation accuracy and compliance.
• Develop and implement equipment reliability strategies that are cost-effective, compliant, and aligned with operational excellence principles.
• Perform or supervise calibrations and maintenance activities on laboratory instruments to ensure accuracy and minimize downtime.
• Define and document equipment specifications through User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS) to support procurement and validation processes.
• Support internal and FDA audits by providing technical expertise and timely responses to observations related to instrumentation.
• Lead or provide SME support for laboratory projects and technology transfer initiatives, translating process needs into equipment requirements.

Qualifications

• Bachelor‚Äôs degree in Chemical, Electrical, Mechanical Engineering, or related technical field.
• Minimum 5 years of experience in pharmaceutical or biopharmaceutical GMP operations (or 9 years in lieu of degree).
• Strong knowledge of FDA regulations, GMP systems, and compliance in highly regulated environments.
• Proven ability to troubleshoot complex technical issues and implement effective solutions.
• Excellent oral and written communication skills, including strong technical writing ability.
• Applied knowledge of Quality by Design and operational excellence tools to improve processes and outcomes.
• Ability to lift and move materials (up to 50 lbs.) safely.

Desirable Qualifications

• Experience supporting laboratory instrumentation in gene therapy or biotechnology environments.
• Project Management certification (e.g., PMP) or advanced degree in a related engineering discipline.

Education

• Not specified beyond the degree requirements above.