Project Quality Lead, Engineering

Make your mark for patients

We are looking for an Project Quality Lead Engineering who isstrategic collaborative and driven by impactto join ourBioNexUS Program Team.Thishybrid position (at least 40% of the time in office) is based inAtlanta Georgia and requires up to 20% domestic & international travel.

About the role

You will operate in a pivotal leadership role within the BioNexUS project UCBs multibilliondollar greenfield investment to build a nextgeneration 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 longterm success of UCBs U.S. biologics manufacturing footprint.

You will work with

As the quality authority for engineering disciplines you will work closely with Engineering Project Management Manufacturing Commissioning & Qualification Quality functions and external suppliers across the BioNexUS project as well as with UCBs global functions. Together with BioNexUS Quality Lead and Quality Lead Digital you will help shape UCBs future biomanufacturing quality approach. As part of the global Engineering Quality team you will collaborate with peers across major CapEx projects and global Engineering Quality Leads to align and harmonize engineering quality standards and ways of working.

What you will do

• 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).

Interested For this position youll need the following education experience and skills

• Masters 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.
• 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.

The reasonably anticipated salary range for this position is $00 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.

Are you ready to go beyond to create value and make your mark for patients If this sounds like you then we would love to hear from you!

About us
UCB is a global biopharmaceutical company focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe inspired by patients and driven by science.

Why work with us
At UCB we dont just complete tasks we create value. We arent afraid to push forward collaborate and innovate to make our mark for patients. We have a caring supportive culture where everyone feels included respected and has equal opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats on our patients our employees or our planet. Working for us you will discover a place where you can grow and have the freedom to carve your own career path to achieve your full potential.

At UCB weve embraced a hybrid-first approach to work bringing teams together in local hubs to foster collaborative curiosity. Unless explicitly stated in the description or precluded by the nature of the position roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employment decisions will be made without regard to any characteristic protected by applicable federal state or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment your employment with UCB or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws orders and regulations.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.