Senior Tech Ops Engineer - Global Technology Transfer Lead

CSL; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

CSL in North Carolina is seeking a Lead Technology Transfer Engineer to drive transfer projects across internal manufacturing sites and external partners, serving as the technical lead to ensure timely delivery and successful transfer objectives.

You will provide expertise for process, equipment, and operational challenges, support regulatory and quality activities, and coordinate cross-functional teams across Manufacturing, MS&T, Quality, Engineering, Regulatory, and Supply Chain to enable

Qualifications

• Bachelor's degree in a biological science or engineering field.
• 3-5 years' hands-on experience in process development activities.
• Knowledge of FDA, EMEA, TGA GMP production regulations.
• Pharmaceutical/biotech experience preferred.
• Local requirements may apply.

Responsibilities

• Lead technology transfer projects across internal sites and external partners, ensuring timely deliverables and transfer objectives.
• Provide technical expertise for process, equipment, and operational challenges and support commercial manufacturing campaigns.
• Author, review, and maintain transfer plans, procedures, batch records, protocols, specs, and related documentation.
• Coordinate cross-functional activities across Manufacturing, MS&T, Quality, Engineering, Regulatory, Supply Chain, CMOs and CDMOs.
• Support regulatory and quality compliance through technical documentation and deviation/ CAPA / OOS investigations.
• Manage readiness activities and plan engineering, demonstration, and validation batches for global commercialization.

Skills

Technology transfer leadership

Cross-functional collaboration

Documentation & record keeping

Regulatory support

GMP / regulatory knowledge

Education

Bachelor's degree in Biological Science or Engineering

Job description

CSL in North Carolina is seeking a Lead Technology Transfer Engineer to drive transfer projects across internal manufacturing sites and external partners, serving as the technical lead to ensure timely delivery and successful transfer objectives.

You will provide expertise for process, equipment, and operational challenges, support regulatory and quality activities, and coordinate cross-functional teams across Manufacturing, MS&T, Quality, Engineering, Regulatory, and Supply Chain to enable