Process Equipment Project Engineer

United Pharma; North Carolina; On-site; USD 110,000 - 140,000; Full time

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.

Skills

Process equipment specification

Procurement of pharmaceutical, biotech

CQV lifecycle

URS & Design Reviews

Job description

United Pharma is seeking an experienced Process Equipment Project Engineer to support a GMP biopharmaceutical manufacturing project. This role focuses on process equipment specification, technical documentation, vendor coordination, procurement support, and facility integration. The ideal candidate will have strong bioprocess equipment expertise and hands‑on experience with the Commissioning, Qualification, and Validation (CQV) lifecycle, including the development of User Requirement Specifications (URS), Design Reviews (DR), and related engineering documents.

Key Responsibilities:

• Review process equipment lists and technical specifications to identify equipment needs, missing details, and technical gaps.
• Develop and maintain URSs, Design Reviews, and other applicable equipment lifecycle and CQV documentation.
• Coordinate technical reviews and gather input from Engineering, Manufacturing, MSAT, Validation, and Quality teams.
• Evaluate equipment space requirements, utility connections, installation access, and compatibility with existing manufacturing facilities.
• Work with facility engineering teams to address equipment integration and installation requirements.
• Support equipment selection, vendor assessments, RFQs/RFPs, technical bid evaluations, and procurement activities.
• Assist with preliminary project budgets, cost estimates, schedules, installation strategies, and CQV planning.

Skills & Qualifications:

• Strong experience specifying and procuring process equipment for pharmaceutical, biotechnology, biologics, or cell and gene therapy manufacturing.
• Demonstrated hands‑on experience preparing URSs, Design Reviews, and other equipment lifecycle documentation.
• Thorough understanding of the equipment commissioning, qualification, and validation lifecycle.