Qualification and Validation Lead (US)

UCB Inc.; Atlanta (GA); On-site; USD 125,600 - 164,900; Full time

Job summary

UCB Inc. in Atlanta, Georgia, is seeking a Qualification and Validation Lead to drive the site's overall qualification and validation strategy within a greenfield biologics project.

You will ensure regulatory and quality compliance, author key documents, and support inspections and regulatory interactions while working with an international team across the United States and Europe.

Qualifications

• Minimum 10 years of qualification and validation experience in regulated environments (biopharma, pharmaceutical or similar).
• Hands-on facility start-up/commissioning experience with transition to routine manufacturing.
• Experience in greenfield or brownfield projects.
• Biotech experience is mandatory.
• In-depth knowledge of quality systems (GxP), including URS, risk assessments, IQ/OQ/PQ.
• Demonstrated ability to author and review qualification and validation documentation (protocols, reports, strategies).
• Minimum 5 years of experience in technology transfer and/or analytical method transfer within industrial manufacturing environments.
• Strong understanding of manufacturing processes and ramp-up activities.

Responsibilities

• Develop, implement, and lead the overall Qualification and Validation strategy for the entire site, while ensuring its successful execution and ongoing compliance across all operations.
• 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.

Skills

Regulatory compliance

GxP knowledge

Documentation writing

Process validation

Cross-functional collaboration

Project management

Biotech experience

Education

Engineering/QA/Manufacturing degree

Job description

UCB is embarking on one of the most significant investments in its history through the development of a new state-of-the-art biologics manufacturing campus in Georgia, USA.

Designed to power the future of biologics, this new facility will strengthen UCB's global manufacturing network, expand supply capabilities for future medicines, and support our long-term ambition of bringing innovative treatments to patients around the world. The project combines cutting-edge technology, sustainability, digital innovation, and operational excellence to create a future‑ready manufacturing ecosystem.

As a true greenfield initiative, it offers a unique opportunity to help design, build, and launch a world‑class biologics manufacturing facility from the ground up while working within a diverse international team spanning the United States and Europe.

We are looking for talented, curious and ambitious individuals who want to make a lasting impact and contribute to shaping the future of biologics manufacturing at UCB.

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 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

• Develop, implement, and lead the overall Qualification and Validation strategy for the entire site, while ensuring its successful execution and ongoing compliance across all operations.
• 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 10 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.
• Experience in greenfield or brownfield projects.
• Experience in biotech is mandatory.
• 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 5 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.

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 [e-mail] 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.