GMP Biopharma Process Equipment CQV Engineer

United Pharma

North Carolina

On-site

USD 110,000 - 140,000

Full time

5 days ago

Be an early applicant

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

United Pharma in North Carolina is seeking an experienced Process Equipment Project Engineer to support a GMP biopharmaceutical manufacturing project. You will focus on process equipment specification, CQV lifecycle, URS development, and cross‑functional coordination with Engineering, Manufacturing, MSAT, Validation, and Quality teams.

You will lead equipment reviews, support procurement activities, and contribute to budgets and installation strategies within CQV planning.

Qualifications

Experience specifying and procuring process equipment for pharma/biotech manufacturing.
Hands-on experience preparing URSs, Design Reviews, and lifecycle documentation.
Thorough understanding of commissioning, qualification, and validation workflows.

Responsibilities

Review process equipment lists and technical specs to identify needs and gaps.
Develop and maintain URSs, Design Reviews, and CQV documentation.
Coordinate technical reviews with Engineering, Manufacturing, MSAT, Validation, and Quality teams.
Evaluate equipment space requirements, utilities, and installation access in facilities.
Work with facility engineering on equipment integration and installation requirements.
Support equipment selection, vendor assessments, RFQs/RFPs, and technical bid evaluations.
Assist with preliminary budgets, cost estimates, schedules, and CQV planning.