Project Engineer II: Biotech Systems & Validation Lead

Merck & Co.; College Station (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies Texas in College Station, TX seeks a Project Engineer to lead engineering projects from concept to closeout, coordinating with facilities, CAPEX, validation, QA/QC and external vendors. Responsibilities include creating specs, reviewing documents, and ensuring regulatory compliance.

The role emphasizes P&IDs, maintenance procedures, equipment commissioning/qualification, and safety adherence while supporting NPIs and CAPEX initiatives.

Qualifications

• Bachelor's degree in engineering (Electrical/Chemical/Mechanical/Biomedical) preferred.
• Minimum of 2 years in an FDA-regulated engineering role.

Responsibilities

• Lead and manage the implementation of assigned engineering projects.
• Develop equipment/system specifications and infrastructure requirements.
• Review project documents (specs, submittals, RFIs, drawings) for accuracy.
• Generate change controls per industry standards and regulatory expectations.
• Coordinate with A&E, GC and vendor teams to advance projects.
• Inspect field progress and ensure quality of tests.
• Review project status and communicate progress and constraints.
• Support CAPEX and NPIs; oversee contractor work as needed.
• Ensure equipment and processes comply with EHS and regulatory guidelines.

Skills

Technical Expertise

Problem Solving

Project Management

Project Execution

Equipment Knowledge

Cross-Functional Collaboration

Communication Skills

Validation & Compliance

Documentation

Regulatory Knowledge

Continuous Improvement

Leadership

Safety & Compliance

Adaptability

Education

Bachelor's Degree in Electrical, Chemical, Mechanical or Biomedical Engineering

Tools

Trackwise

MS Office

Project Management Software

Job description

FUJIFILM Biotechnologies Texas in College Station, TX seeks a Project Engineer to lead engineering projects from concept to closeout, coordinating with facilities, CAPEX, validation, QA/QC and external vendors. Responsibilities include creating specs, reviewing documents, and ensuring regulatory compliance.

The role emphasizes P&IDs, maintenance procedures, equipment commissioning/qualification, and safety adherence while supporting NPIs and CAPEX initiatives.