Senior Engineer, Tech Ops - CSL Seqirus

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

• Lead technology transfer projects across internal manufacturing sites and external partners, serving as the technical lead and ensuring successful execution of project deliverables, timelines, and transfer objectives.
• Provide technical expertise and manufacturing support for process, equipment, and operational challenges, including troubleshooting, technical investigations, risk assessments, and support of commercial manufacturing campaigns.
• Author, review, and maintain technical documentation including transfer plans, assessments, procedures, batch records, protocols, specifications, reports, training materials, and related compliance documentation.
• Drive project execution and cross-functional collaboration by coordinating activities across Manufacturing, MS&T, Quality, Engineering, Regulatory, Supply Chain, and external partners, including CMOs and CDMOs, to achieve project milestones and business objectives.
• Maintain process, equipment, and automation knowledge to support technology transfer, process performance, and continuous improvement initiatives that enhance yield, reliability, robustness, safety, and operational efficiency
• Support Regulatory and Quality compliance activities through preparation of technical documentation, support of submissions and health authority responses, and participation in deviations, change controls, CAPAs, OOS, OOE, and complaint investigations.
• Manage manufacturing readiness activities, including material enrollments, BOM updates, manufacturing system changes, and the planning, execution, and support of engineering, demonstration, and validation batches to ensure successful process implementation and commercialization across a global manufacturing network.

Qualifications:

• Bachelor's degree in a relevant branch of Biological Science or Engineering
• 3-5 years' hands‑on experience in process development activities
• Knowledge of the regulations (FDA, EMEA, TGA) associated with GMP production
• Pharmaceutical/biotech experience preferred
• Different qualifications or responsibilities may apply based on local legal and/or educational requirements.
• Refer to local job documentation where applicable.

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state‑of‑the‑art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.