Qualification and Validation Lead (US)
About The Position
UCB is establishing a new, state-of-the-art biologics manufacturing campus in Georgia, USA, representing a significant investment to enhance its global manufacturing capabilities and support the delivery of innovative treatments. This greenfield project offers a unique opportunity to shape a future-ready manufacturing ecosystem from its inception, integrating cutting-edge technology, sustainability, and digital innovation. The Qualification and Validation Lead will play a crucial role in this initiative, ensuring that all manufacturing systems, equipment, and processes are designed, delivered, and maintained in compliance with stringent regulatory and quality standards. This position contributes to building a compliant and inspection-ready facility by embedding validation principles throughout the project lifecycle within a dynamic and evolving project environment.
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 the 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.
Nice To Haves
- 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.
Responsibilities
- Develop, implement, and lead the overall Qualification and Validation strategy for the entire site, ensuring successful execution and ongoing compliance across all operations.
- Define and represent qualification and validation requirements throughout the project.
- Ensure compliance with regulatory and quality standards during the design and delivery phases.
- Review and assess technical documentation pertinent to validation activities.
- Contribute to inspection readiness and provide support for audit and regulatory interactions.
- Translate operational and regulatory expectations into concrete project requirements.
- Promote a strong culture of quality and compliance among all stakeholders.
Benefits
- Hybrid-first approach to work
- Opportunity for professional growth and career path development
- Caring, supportive culture where everyone feels included and respected
- Equal opportunities for all employees
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
