Process Equipment Project Engineer – CQV

Job Title: Process Equipment Project Engineer CQV

Company: Novozen health care

Location: Durham, NC (100% Onsite)

Employment Type: Contract (W2)

Job Responsibilities

• Review process equipment specifications, identify technical gaps, and ensure compatibility with GMP biopharmaceutical manufacturing requirements.

• Develop and review CQV documentation, including User Requirement Specifications (URS), Design Reviews (DR), and equipment lifecycle documents.

• Evaluate equipment installation, utility, space, and facility integration requirements.

• Support equipment procurement, vendor evaluations, RFQs/RFPs, and technical bid reviews.

• Assist with project cost estimates, schedules, installation planning, and CQV activities.

• Collaborate with Manufacturing, MSAT, Validation, Quality, Facilities, and Engineering teams to resolve technical issues.

Required Qualifications

• Strong hands-on experience with pharmaceutical, biologics, or cell and gene therapy process equipment.

• Proven experience in equipment specification, selection, procurement, and facility integration.

• Strong understanding of the complete Commissioning, Qualification, and Validation (CQV) lifecycle.

• Hands-on experience preparing URS, Design Reviews (DR), and other GMP equipment qualification documentation.

• Experience evaluating equipment utility requirements, installation needs, and operational specifications.

• Knowledge of vendor technical reviews, RFQs/RFPs, and procurement processes.

• Strong understanding of GMP regulations and biopharmaceutical manufacturing environments.

• Excellent project coordination, technical documentation, problem-solving, and cross-functional communication skills.

• Ability to work independently and manage multiple project deliverables.

Pay Scale

Anticipated hourly pay range: $54/hr to $63/hr on W2

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.