Lead Tech Ops Engineer - Global GMP Transfers

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

Job summary

CSL Seqirus in the United States seeks a process development professional to lead technology transfer projects across internal sites and external partners. You will provide manufacturing expertise for process, equipment, and operations, and support commercial campaigns and investigations.

Responsibilities include drafting transfer plans, batch records, procedures, and regulatory documents; coordinating with Manufacturing, QA, Regulatory, and Supply Chain to reach milestones; and driving

Qualifications

• Bachelor's degree in Biological Science or Engineering required.
• 3-5 years hands-on experience in process development activities.
• Knowledge of FDA/EMEA/TGA regulations for GMP production.
• Pharmaceutical/biotech experience preferred.
• Local regulatory requirements may vary; refer to local documentation.

Responsibilities

• Lead technology transfer projects across internal manufacturing sites and external partners.
• Provide technical expertise for process, equipment, and operations; support campaigns.
• Author and maintain transfer plans, assessments, procedures, batch records, and reports.
• Coordinate cross-functional activities to achieve milestones with CMOs/CDMOs.
• Support regulatory compliance through deviations, CAPAs, and investigations.
• Manage readiness activities including material enrollments and validation batches.

Skills

3-5 years hands-on experience in

Education

Bachelor's degree in Biological Science or Engineering

Job description

CSL Seqirus in the United States seeks a process development professional to lead technology transfer projects across internal sites and external partners. You will provide manufacturing expertise for process, equipment, and operations, and support commercial campaigns and investigations.

Responsibilities include drafting transfer plans, batch records, procedures, and regulatory documents; coordinating with Manufacturing, QA, Regulatory, and Supply Chain to reach milestones; and driving