BioNexUS Qualification and Validation Lead, Atlanta GA

Qualification and Validation Lead This position is based in Atlanta, Georgia and requires domestic & international travel. About The Role This role contributes 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 help build a compliant and inspection‑ready facility by integrating validation principles throughout the project lifecycle in a rapidly evolving environment. 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. Who You’ll Work With You will work in a team that collaborates with manufacturing sites, quality experts and project stakeholders, focusing on compliance, regulatory alignment, and inspection readiness across 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. Qualifications 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. Salary The anticipated salary range for this position is $125,600 - $164,900 per year. The actual salary offered will be based on knowledge, skills, experience and location. Equal Opportunity Employment 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 View email address on click.appcast.io 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. #J-18808-Ljbffr UCB