Senior Engineer, Tech Ops

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

Job summary

CSL Plasma in North Carolina is seeking an experienced process development professional to lead technology transfer projects across internal sites and external partners. You will provide technical manufacturing support, author and maintain documentation, coordinate cross-functional activities, and drive continuous improvement to enhance yield, reliability, and compliance in a global network.

Candidates should have a BS in Biological Science or Engineering and 3–5 years in GMP biopharma process

Qualifications

• Bachelor's degree in Biological Science or Engineering; 3–5 years' hands-on process development experience.
• Familiar with GMP regulations (FDA, EMEA, TGA).
• Pharmaceutical/biotech experience preferred.

Responsibilities

• Lead technology transfer projects across internal manufacturing sites and external partners.
• Provide technical manufacturing support for process, equipment, and operational challenges; troubleshoot and perform investigations.
• Author, review, and maintain technical documentation including transfer plans, batch records, protocols, and reports.
• Drive project execution with cross-functional teams across Manufacturing, MS&T, Quality, Engineering, Regulatory, and Supply Chain.
• Maintain process, equipment, and automation knowledge to support transfer, process performance, and continuous improvement.
• Support regulatory and quality activities through documentation and participation in deviations, CAPAs, OOS, and investigations.
• Manage manufacturing readiness activities, including material enrollments, BOM updates, and planning/execution of demonstration and validation batches.

Skills

Technology transfer

Cross-functional collaboration

Manufacturing support

Technical documentation

Regulatory compliance

Education

Bachelor's degree in Biological Science or Engineering

Job description

Responsibilities:

• 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.