Qualification and Validation Lead (US)

Make your mark for patients

We are looking for a Qualification and Validation Lead who is collaborative, rigorous and proactive to join us in our Internal Manufacturing team. This position is  based in Atlanta, Georgia and requires domestic & international travel.

About the role

This role is part of a project, contributing to the design and delivery of a future-ready biologics manufacturing facility. You will ensure that manufacturing systems, equipment and processes are designed and delivered in compliance with regulatory and quality requirements. You will contribute to building a compliant and inspection-ready facility by integrating validation principles throughout the project lifecycle in a rapidly evolving project environment.

Who you’ll work with

You will be working in a team that collaborates with manufacturing sites, quality experts and project stakeholders. The team focuses on ensuring compliance, alignment with regulatory expectations and readiness for inspections working across different time zones.

What you’ll do

• Define and represent qualification and validation requirements across the project.


• Ensure compliance with regulatory and quality standards throughout design and delivery.


• Review and assess technical documentation related to validation activities.


• Contribute to inspection readiness and support audit and regulatory interactions.


• Translate operational and regulatory expectations into project requirements.


• Promote strong quality and compliance culture across stakeholders.

Interested? For this role we’re looking for the following education, experience and skills

Mandatory requirements

• Minimum 7 years of experience in qualification and validation activities within regulated environments (biopharma, pharmaceutical or similar), gained from Engineering, QA, or Manufacturing roles.


• Hands-on experience during facility start-up / commissioning phases, with strong exposure to the transition from project delivery to routine manufacturing operations.


• In-depth knowledge of quality systems (GxP), including qualification and validation lifecycle (URS, risk assessments, IQ/OQ/PQ).


• Demonstrated ability to autonomously author and review qualification and validation documentation (protocols, reports, strategies).


• Minimum 3 years of experience in technology transfer and/or analytical method transfer within industrial manufacturing environments.


• Strong understanding of manufacturing processes, with the ability to assess operational readiness and support ramp-up activities.

Strong plus

• Background in production/manufacturing environments, with a solid understanding of shopfloor realities and constraints.


• Experience working in multi-product facilities, with an understanding of associated challenges.

The reasonably anticipated salary range for this position is $ 125.600 - 164,900   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 don’t just complete tasks, we create value. We aren’t 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 that’s 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, we’ve 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 employer. All 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 [email protected] 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.