Commissioning & Qualification Engineer

Position: Commissioning & Qualification Engineer Location: North Carolina, United States Duration: 12+ Months Contract Experience: 5+ Years

About the Role

We are seeking an experienced Commissioning & Qualification Engineer to support commissioning, qualification, and validation (CQV) activities for Simple Direct Impact Process Support Equipment at a new biopharmaceutical manufacturing facility on the East Coast. This role is ideal for someone with a strong background in equipment qualification, project execution, and collaboration across multiple technical teams.

Key Responsibilities

Provide CQV support for all Simple Direct Impact Process Support Equipment and No Impact Equipment across multiple buildings.

Collaborate with equipment and area owners from design and procurement through qualification and final handover .

Coordinate with sub-contractors and vendors on equipment readiness, construction progress, and testing schedules.

Participate in field walkdowns , vendor onboarding, and test execution scheduling .

Review and approve Vendor and Contractor Turnover Packages related to assigned systems and equipment.

Work closely with the CQV SWAT Team to manage punchlist closure both before mechanical completion (M/C) and during execution phases.

Support documentation efforts and ensure all CQV deliverables meet quality, regulatory, and schedule requirements.

Qualifications and Experience

• 5+ years of relevant CQV or equipment engineering experience, preferably in large-scale biopharmaceutical projects .

• Solid understanding of process support equipment and associated qualification protocols .

• Experience working on complex capital projects or within operating manufacturing environments .

• Strong organizational and planning skills with the ability to manage multiple priorities and deadlines.

• Effective communication and collaboration skills for working with internal teams, vendors, and operations staff.

• Proven ability to perform in dynamic project environments and adapt to evolving business needs.