BioNexUS Qualification and Validation Lead, Atlanta GA

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.

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.

Reasonably Anticipated Salary Range

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.