| Location | Nags Head, NC |
| Job Type | Contractor |
| Salary | $45–$48 Per Hour |
We are seeking an experienced Process Equipment Project Engineer – CQV to support equipment specification, procurement, facility integration, and commissioning, qualification, and validation activities for a GMP biopharmaceutical manufacturing project. The consultant will review process equipment requirements, evaluate installation and utility needs, coordinate facility integration, and develop key CQV lifecycle documentation including URS, Design Reviews, and qualification-related documents. The role will work closely with Engineering, Manufacturing, MSAT, Validation, Quality, Facilities, and external vendors to support equipment selection, procurement, installation, and project execution.
Review planned process equipment lists, equipment specifications, and technical requirements to identify gaps, missing information, and technical risks.
Develop and maintain User Requirement Specifications (URS), Design Reviews (DR), and other CQV lifecycle documentation.
Coordinate technical reviews and obtain input from Engineering, Manufacturing, Validation, Quality, Facilities, and other SMEs.
Evaluate equipment space, utility, access, installation, operational, and qualification requirements.
Coordinate with Facility Engineering to confirm equipment compatibility with existing manufacturing suites.
Support equipment selection, vendor evaluations, RFQs/RFPs, technical bid evaluations, and procurement activities.
Review vendor documentation and resolve technical questions and equipment-related issues.
Support preliminary equipment cost estimates, project schedules, installation planning, and CQV planning.
Coordinate equipment-related project scope, deliverables, technical reviews, and vendor activities.
Support equipment commissioning, qualification, validation, and lifecycle activities.
Proactively identify missing technical information, risks, dependencies, and project gaps and drive them to resolution.
Maintain clear engineering and CQV documentation in accordance with GMP and project requirements.
Strong hands-on experience with pharmaceutical, biologics, bioprocess, or cell and gene therapy process equipment.
Experience with equipment specification, selection, procurement, and facility integration.
Strong understanding of the Commissioning, Qualification & Validation (CQV) lifecycle.
Hands-on experience authoring URS, Design Reviews (DR), equipment specifications, and CQV documentation.
Ability to evaluate equipment space, utilities, installation, operational, and qualification requirements.
Experience supporting vendor evaluations, RFQs/RFPs, technical bid reviews, and procurement activities.
Strong understanding of GMP engineering and documentation requirements within pharmaceutical or biologics manufacturing.
Experience coordinating project scope, vendors, cost estimates, schedules, installation, and project deliverables.
Experience working with Manufacturing, MSAT, Validation, Quality, Facilities, and Engineering teams.
Strong technical documentation, communication, coordination, and problem-solving skills.
Ability to work independently and proactively gather information, develop documentation, and resolve technical issues.