Senior Engineer, Tech Ops

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

• 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.

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.