Biotech Project Engineer: CapEx & Validation

FUJIFILM Holdings America Corporation; College Station (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies Texas is seeking a Project Engineer to lead and coordinate engineering projects across facilities in College Station, TX. You will develop specifications, review documents, and ensure changes meet regulatory and quality standards.

Role interacts with CAPEX, QA/QC, validation, and external contractors to drive projects from conception through closeout, while maintaining a safe and compliant work environment.

Qualifications

• Bachelor's degree in Electrical, Chemical, Mechanical or Biomedical Engineering (preferred).
• Two years or more experience in an FDA-regulated engineering role (minimum).
• Knowledge of Trackwise or similar quality management software is a plus.

Responsibilities

• Lead, prepare, coordinate, monitor and manage the implementation of assigned engineering projects.
• Develop equipment/system specifications, identify infrastructure requirements and perform capability assessments.
• Review, markup and ensure project documents are created and documented accurately.
• Generate change controls conforming with industry standards and regulatory expectations.
• Coordinate with A&E designers, general contractors and vendors.
• Inspect field progress and ensure tests are valid and compliant.

Skills

Project Management

Leadership

Communication

Regulatory Knowledge

Problem Solving

MS Office

Trackwise

Education

Bachelor's Degree in Electrical/Chemical/Mechanical/Biomedical Engineering

Tools

MS Office

Trackwise

Job description

FUJIFILM Biotechnologies Texas is seeking a Project Engineer to lead and coordinate engineering projects across facilities in College Station, TX. You will develop specifications, review documents, and ensure changes meet regulatory and quality standards.

Role interacts with CAPEX, QA/QC, validation, and external contractors to drive projects from conception through closeout, while maintaining a safe and compliant work environment.