Project Quality Lead, Engineering

About the role

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).

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).

Requirements

• Master’s degree in Engineering or a related scientific field (or equivalent experience).
• 8+ 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.
• 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.
• 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.

Qualifications

• Master’s degree in Engineering or a related scientific field (or equivalent experience).
• 8+ 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.
• 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.
• 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.

Skills

• Strong knowledge of current Good Manufacturing Practice and regulatory expectations (Food and Drug Administration, European Union).
• Experience with commissioning, qualification, and vendor oversight.
• 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.
• 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.

Benefits

The reasonably anticipated salary range for this position is $148,000-194,300 per year. The actual salary offered will take into account related knowledge, skills, experience and location among other factors and may fall outside the expected range.

Pay

The reasonably anticipated salary range for this position is $148,000-194,300 per year. The actual salary offered will take into account related knowledge, skills, experience and location among other factors and may fall outside the expected range.

Schedule

This hybrid position (at least 40% of the time in office) is based in Atlanta, Georgia and requires up to 20% domestic & international travel.