Facilities Engineer III: Biotech GMP Lead

KBI Biopharma, Inc.; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC is seeking a Facilities Engineer III to provide technical support for ongoing operations and act as a system owner for facilities' systems.

The role includes project management, compliance oversight, and participation in the design, commissioning, and validation of new or modified systems. The ideal candidate will have a BS in engineering with 5–6 years of relevant experience (or an MS with 2–3 years), strong analytical abilities, and knowledge of cGMP

Qualifications

• Bachelor of Science in mechanical, chemical, or electrical engineering and 5-6 years of related facilities development, construction, and maintenance activities.
• Or Master of Science in mechanical, chemical, or electrical engineering and 2-3 years of related facilities development, construction, and maintenance activities.
• Preferred: facilities management experience in a cGMP manufacturing environment (biotech, pharmaceutical or medical device industries).
• Knowledge of facility operations typical to biotechnology/pharmaceutical industry.
• Knowledge of federal, state, and local building code requirements.

Responsibilities

• Direct technical and management aspects of multiple projects to ensure on-time delivery, project compliance, budget, and required deliverables.
• Support Maintenance and Facilities functions for multiple locations including corrective and preventative maintenance and repair of facilities, utilities, and equipment.
• Support Validation with the planning and execution of commissioning and validation protocols.
• Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems.
• Develop and maintain standard operating procedures and other procedures for installed systems.

Skills

Analytical skills

Communication

Education

Bachelor of Science in mechanical, chemical, or electrical engineering

Master of Science in mechanical, chemical, or electrical engineering

Tools

Microsoft Office

AutoCAD

Job description

KBI Biopharma, Inc. in Durham, NC is seeking a Facilities Engineer III to provide technical support for ongoing operations and act as a system owner for facilities' systems.

The role includes project management, compliance oversight, and participation in the design, commissioning, and validation of new or modified systems. The ideal candidate will have a BS in engineering with 5–6 years of relevant experience (or an MS with 2–3 years), strong analytical abilities, and knowledge of cGMP