Senior Engineer, Tech Ops

CSL Plasma; Holly Springs (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

CSL Plasma in the United States is seeking a hands-on professional to lead technology transfer projects and provide manufacturing support for process, equipment, and operations. You will author and maintain critical transfer documentation and coordinate cross-functional activities across Manufacturing, Quality, Regulatory, and external partners to meet milestones and enable commercialization.

The role emphasizes risk assessment, technical investigations, and continuous improvement to improve

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.

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.

Skills

Tech transfer

Process development

Troubleshooting

Cross-functional collaboration

Education

BSc 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.

#GTA