Biotech Project Engineer II: NPI & CAPEX Lead

FUJIFILM Biotechnologies; College Station (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies Texas in College Station seeks a Project Engineer to lead and coordinate engineering projects, develop specs, review documents, and ensure compliance with GMP and FDA guidelines. You will work with facilities, CAPEX, QA/QC, validation, and external contractors.

You will support P&ID development, equipment commissioning, IQ/OQ/PQ activities, and implement change controls while maintaining safety and regulatory standards.

Qualifications

• Bachelor’s degree in Electrical, Chemical, Mechanical or Biomedical Engineering.
• Two years of engineering experience in an FDA-regulated facility.
• Strong project management and cross-functional coordination.
• Experience with equipment validation and IQ/OQ/PQ is preferred.

Responsibilities

• Lead and manage the implementation of assigned engineering projects.
• Develop equipment/system specifications and infrastructure requirements.
• Coordinate with A&E firms, general contractors and vendors.
• Inspect field progress and ensure documentation accuracy.
• Support CAPEX, NPIs and validation activities as required.

Skills

Project management

Cross-functional collaboration

Documentation & reporting

Regulatory compliance

Problem solving

Communication

Education

Bachelor’s degree in Electrical, Chemical, Mechanical or Biomedical Engineering

FDA-regulated facility experience

Tools

MS Office

Project management software

Job description

FUJIFILM Biotechnologies Texas in College Station seeks a Project Engineer to lead and coordinate engineering projects, develop specs, review documents, and ensure compliance with GMP and FDA guidelines. You will work with facilities, CAPEX, QA/QC, validation, and external contractors.

You will support P&ID development, equipment commissioning, IQ/OQ/PQ activities, and implement change controls while maintaining safety and regulatory standards.