GMP Bioprocess Equipment Project Engineer

United Pharma; Durham (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

United Pharma in Durham, NC seeks an experienced Process Equipment Project Engineer to support equipment specification, procurement, and facility integration for a GMP biopharmaceutical manufacturing project.

You will review the planned process equipment list, identify installation and utility requirements, and collaborate with Facilities, Utilities, Process Engineering, and Manufacturing to ensure compatibility with the existing suite.

Qualifications

• Experience reviewing GMP process equipment for pharma/biologics projects.
• Ability to identify space, utility, installation, operational and validation needs.
• Experience developing User Requirement Specifications for GMP equipment.
• Experience supporting RFQ/RFP processes and technical bid reviews.
• Coordinate equipment installation with Facilities, Utilities, Process Eng, and Manufacturing.
• Strong understanding of GMP engineering requirements in regulated environments.
• Knowledge of CQV activities including commissioning, qualification, and validation.
• Proven ability to coordinate scope, vendors, cost estimates, schedules, and deliverables.
• Ability to collaborate with Manufacturing, MSAT, Validation, Quality, Facilities, and Engineering.
• Independent execution: drive issues to resolution with minimal direction.

Responsibilities

• Review planned process equipment list and technical specifications.
• Identify installation and utility requirements.
• Support vendor selection, RFQ/RFP, and technical bid reviews.
• Develop equipment URS and CQV planning inputs.
• Partner with facility engineering to confirm compatibility with existing suite.
• Drive portions of the vendor/RFP process and preliminary cost/schedule.

Skills

Bioprocess Equipment

Equipment Specifications

URS Development

Equipment Procurement

Facility Integration

GMP Environment

CQV

Project Engineering

Cross-Functional Collaboration

Independent Execution

Job description

United Pharma in Durham, NC seeks an experienced Process Equipment Project Engineer to support equipment specification, procurement, and facility integration for a GMP biopharmaceutical manufacturing project.

You will review the planned process equipment list, identify installation and utility requirements, and collaborate with Facilities, Utilities, Process Engineering, and Manufacturing to ensure compatibility with the existing suite.