CQV Upstream Engineer

Job Title: CQV Upstream Engineer Location: North Carolina, United States

We are seeking an experienced Senior CQV Engineer to lead Commissioning, Qualification, and Validation (CQV) activities for upstream equipment in a biopharmaceutical manufacturing facility. This role focuses on the DSM Building project and requires deep expertise in CQV processes, upstream systems, and equipment lifecycle management.

Key Responsibilities:

Review all design deliverables including drawings, datasheets, specifications, and engineering lists related to upstream systems.

Support the generation of CQV documentation, including:

FAT wraparounds

Design Qualification (DQ)

Requirement Traceability Matrix (RTM)

Quality Risk Assessment (QRA)

Site Acceptance Testing (SAT), Installation & Operational Qualification (IOC/IOQ)

Final reports and documentation packages

Create the upstream bridging document, ensuring alignment with Process Science (PS) for Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).

Act as the primary CQV contact for vendor package reviews in the upstream area.

Serve as the CQV Subject Matter Expert (SME) for all upstream systems.

Lead CQV reviews and align with the Transition Group for the review and approval of all turnover packages (vendor and contractor) related to process equipment.

Collaborate with the CQV SWAT team to manage punch list items before Mechanical Completion (M/C) and during execution.

Coordinate with the CQV Project Manager and Lead Scheduler to manage scheduling, ensuring proper sequencing and dependencies.

Ensure all upstream systems are commissioning-ready to support equipment start-up and IOQ testing.

Lead field execution for PSSR (Pre-Startup Safety Review) and STW (System Turnover Walkdowns).

Guide the CQV team through safe and controlled equipment start-up.

Requirements

• Extensive experience in CQV, particularly for upstream biopharma equipment.

• Ability to work independently with minimal supervision.

• Willingness and ability to travel for Factory Acceptance Tests (FATs).

• Strong cross-functional collaboration skills with internal departments and project leadership.

• Hands-on experience in design, construction, and CQV of biopharmaceutical manufacturing facilities.

• Proven leadership in managing CQV activities and teams on complex projects.

• Experience working in or around active operating facilities.

• Excellent organizational and planning skills with the ability to meet tight deadlines.

• Strong communication skills for interfacing with clients, vendors, equipment suppliers, and operational teams.