Biopharma Facilities & Engineering Executive

NCBioImpact; Durham (NC); On-site; USD 180,000 - 300,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC, seeks a Vice President of Facilities and Engineering to lead the site’s building, equipment, and system performance.

You will coach engineering, validation, maintenance, and capital project staff to ensure design and operation meet safety, quality, and regulatory standards. You will develop strategies, processes, and metrics to maximize facility availability, reliability, and performance, while aligning with Finance, Manufacturing, MS&T, QC, and Quality

Qualifications

• Bachelor’s degree in an engineering discipline required; 15+ years engineering experience with 10+ years in biotech and 5+ years in management.
• Established expertise in biopharmaceutical manufacturing and equipment design/qualification.
• Strong technical writing and communication skills.
• Broad understanding of codes and cGMP requirements across regulatory jurisdictions.

Responsibilities

• Direct engineering, validation, capital project, and maintenance activities for the site.
• Oversee maintenance and repair of facilities, utilities, and equipment; drive improvements.
• Represent Facilities & Engineering in client audits and regulatory inspections.
• Ensure procedures and systems are compliant and implement metrics for effectiveness.
• Oversee staff leadership, coaching, and performance management.
• Develop and execute drive for improvements and objective achievement.
• Plan resources and manage performance including mentoring and discipline.

Skills

Biopharma process knowledge

Technical writing

Negotiation

Regulatory compliance

Project management

Leadership

Quality systems

Communication

Education

Bachelor’s degree in engineering

Tools

MS Office

MS Excel

Engineering software

MS Project

Job description

KBI Biopharma, Inc. in Durham, NC, seeks a Vice President of Facilities and Engineering to lead the site’s building, equipment, and system performance.

You will coach engineering, validation, maintenance, and capital project staff to ensure design and operation meet safety, quality, and regulatory standards. You will develop strategies, processes, and metrics to maximize facility availability, reliability, and performance, while aligning with Finance, Manufacturing, MS&T, QC, and Quality