Senior Process Engineer

Job Title: Senior Process / Facility Fit Engineer

Location: Durham, NC

Duration: 3 months initially, with potential extension

Employment Type: W2





Job Summary

We are looking for a Senior Process / Facility Fit Engineer to support a preliminary facility-fit study within a regulated biopharmaceutical manufacturing environment.





What you'll do:


- Evaluate process equipment against existing GMP facility capabilities.
- Perform facility-fit and equipment/facility gap assessments.
- Review equipment specifications and GMP process layouts.
- Evaluate equipment placement, accessibility, ergonomics, and personnel/material flow.
- Identify facility and utility gaps and recommend modifications.
- Support preliminary URS development.
- Provide input on CQV requirements, project costs, schedules, and implementation planning.
- Work closely with Process, Manufacturing, MSAT, Facilities, Validation, Quality, and Engineering teams.
- Lead technical discussions and document recommendations.






What we're looking for:


- Senior engineering experience in biopharma, biologics, pharmaceutical, cell & gene therapy, or a similar GMP environment.
- Experience with facility-fit studies, equipment integration, or gap assessments.
- Strong understanding of GMP process layouts and biopharmaceutical equipment.
- Knowledge of process utilities and facility requirements.
- Experience with URS and CQV activities.
- USP and/or DSP experience strongly preferred.
- Strong technical communication and cross-functional leadership skills.