Principal Engineer, Tech Ops

CSL Plasma•Waltham, MA

12h

About The Position

This role is a Principal Engineer position in the Drug Delivery Systems and Packaging (DDSP) department within CSL TechOps. In this role you will be responsible for bringing new Drug Delivery Systems through the development process. You will have considerable cross-functional interactions, that include Quality Assurance, Regulatory Affairs, Packaging, CMC, Clinical and Commercial functions. Specific Accountabilities, Responsibilities and Activities: Responsible for the planning and execution of projects for evaluation, selection, improvement, and implementation of new or existing primary packaging materials, medical devices, and Combination Products for CSL products. Collaborate with key stakeholders in CSL to evaluate new device technologies to meet pipeline needs. Be the Technical Lead to effectively handle commercial biological/drug-device combination product development. Guide integration of device development with CMC, Primary Container, and Verification and Testing workstreams to influence and enable CSL clinical asset development strategy. Application of expertise in Design Controls and Risk Management (ISO 13485, ISO 14971, and 21 CFR 820), EU MDR requirements, compilation and maintenance of Design History Files, design verification and validation, and clinical trial/commercial manufacture support. Ensure control strategy and test methods are appropriately developed and qualified to inform design decision-making and enable control of device/containers/packaging performance. Create and maintain standard operating procedures, work instructions, and templates for DDSP to use in the development of combination products. Work closely with Business Units, Affiliates, and Manufacturing to ensure the appropriate qualification of finished product and the successful tech transfer to manufacturing sites to enable commercial strategies. Provide in-depth technical advice and guidance beyond DDSP department. Work with CMC, Operations, and QC lab organizations to assess projects for design and process risks and use resources to mitigate those risks before they affect the project delivery timeline. Provide device development and combination product timelines for projects. Provide device development budget input for projects. Author and or review technical documents for regulatory submissions and responses to regulatory agency questions on combination products. Ensure data integrity and scientific consistency in all testing. Promote data analysis using advanced statistical techniques.

Requirements

At least 5 years in drug delivery device development with relevant pharma industry experience or other highly regulated environment.
University level education; ideally a Masters or PhD in Biomedical Engineering, Electrical or Mechanical Engineering or in a related field.
Proven ability to develop strategies and lead improvement projects.
Excellent communication skills and a track record working in a matrix environment; Influencing/building/promoting a culture of continuous improvement.
Experience with regulatory and quality standards and generation of documentation to support quality assessments and for submission to regulatory agencies.

Responsibilities

Responsible for the planning and execution of projects for evaluation, selection, improvement, and implementation of new or existing primary packaging materials, medical devices, and Combination Products for CSL products.
Collaborate with key stakeholders in CSL to evaluate new device technologies to meet pipeline needs.
Be the Technical Lead to effectively handle commercial biological/drug-device combination product development.
Guide integration of device development with CMC, Primary Container, and Verification and Testing workstreams to influence and enable CSL clinical asset development strategy.
Application of expertise in Design Controls and Risk Management (ISO 13485, ISO 14971, and 21 CFR 820), EU MDR requirements, compilation and maintenance of Design History Files, design verification and validation, and clinical trial/commercial manufacture support.
Ensure control strategy and test methods are appropriately developed and qualified to inform design decision-making and enable control of device/containers/packaging performance.
Create and maintain standard operating procedures, work instructions, and templates for DDSP to use in the development of combination products.
Work closely with Business Units, Affiliates, and Manufacturing to ensure the appropriate qualification of finished product and the successful tech transfer to manufacturing sites to enable commercial strategies.
Provide in-depth technical advice and guidance beyond DDSP department.
Work with CMC, Operations, and QC lab organizations to assess projects for design and process risks and use resources to mitigate those risks before they affect the project delivery timeline.
Provide device development and combination product timelines for projects.
Provide device development budget input for projects.
Author and or review technical documents for regulatory submissions and responses to regulatory agency questions on combination products.
Ensure data integrity and scientific consistency in all testing.
Promote data analysis using advanced statistical techniques.