BioNexUS Quality Lead Engineering

UCB•Atlanta, GA

5d•Hybrid

About The Position

This hybrid position (at least 40% of the time in office) is based in Atlanta, Georgia and requires up to 20% domestic & international travel. You will operate in a pivotal leadership role within the BioNexUS project, UCB’s multi‑billion‑dollar greenfield investment to build a next‑generation biologics manufacturing facility in the metropolitan Atlanta area, Georgia (USA). This role is instrumental in ensuring that quality is embedded by design throughout the project lifecycle. Reporting to the BioNexUS Quality Lead, the position provides quality oversight for all engineering activities during design and execution, ensuring compliance with regulatory requirements, UCB standards, and project objectives. This role offers a unique opportunity to shape quality strategy and practices for a flagship UCB investment, contributing directly to patient safety, regulatory readiness, and the long‑term success of UCB’s U.S. biologics manufacturing footprint.

Requirements

Master’s degree in Engineering or a related scientific field (or equivalent experience).
10+ years of experience in Good Practice regulated quality, engineering quality, qualification, or validation in pharmaceutical or biotechnology manufacturing.
Experience supporting large capital projects (greenfield or major expansions preferred).
Strong knowledge of current Good Manufacturing Practice and regulatory expectations (Food and Drug Administration, European Union).
Experience with commissioning, qualification, and vendor oversight.
Ability to assess risk, solve problems pragmatically, and manage complexity.
Strong understanding of digital, automated, and computerized systems and data integrity principles.
Excellent communication and collaboration skills.
Proactive, structured, and adaptable in a fast-paced environment.

Nice To Haves

Familiarity with American Society for Testing and Materials E2500, International Society for Pharmaceutical Engineering Baseline Guide Volume 5, and Good Automated Manufacturing Practice 5 is a plus.

Responsibilities

Act as the quality partner across engineering workstreams (premises, equipment, utilities) from design through qualification.
Ensure quality by design using a phase-appropriate, risk-based approach aligned with current Good Manufacturing Practice requirements and UCB standards.
Review and approve key deliverables, including User Requirements Specifications, design documents, risk assessments, and commissioning and qualification strategies and reports, providing quality oversight.
Lead qualification activities (Installation, Operational, and Performance Qualification) for facilities, equipment, utilities, and systems.
Ensure designs incorporate cleaning validation strategies.
Oversee vendor quality, including qualification, audits, and agreements.
Develop and approve Standard Operating Procedures and controlled documents across engineering, validation, and lifecycle management.
Provide guidance on digital and automated solutions, ensuring compliance and data integrity.
Identify and manage quality and regulatory risks, ensuring timely mitigation (FDA, EMA).
Support inspection readiness and regulatory interactions (Food and Drug Administration, European Medicines Agency, and other health authorities).