Engineer II, Technology Transfer (Manufacturing Sciences & Technology)
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The incumbent will be a member of the Global Manufacturing Sciences & Technology Tech Transfer team located at Holly Springs Influenza Vaccine manufacturing facility, dedicated to supporting the transfer and qualification of drug substance and drug product vaccine manufacturing processes. These processes include, but are not limited to, self-amplifying mRNA (SAM) GMP clinical vaccine process designs through Commercial approval. The MS&T TT function provides ownership, oversight and strategic technical direction to manufacturing organizations to achieve supply targets and maximize capacity. This position has responsibilities that include providing technical expertise related to the process, equipment, and business systems that drive strategic implementation and qualification of new processes within the TD, Drug Substance and Fill Finish sub-units. Provide front line support of production and process-specific issues from process scoping through routine production of GMP material. This position will also be responsible for working with the TD and the Holly Springs Manufacturing areas to lead Tech Transfer(s), ensuring the processes are aligned and right the first time.Major Responsibilities:
Provide leadership to the product transfer team as the primary point of contact for technical and operational equipment/process issues. Define, scope, execute and when needed troubleshoot and investigate equipment/product problems in the manufacturing facility while coordinating with appropriate teams to resolve issues and prevent reoccurrence. Provide technical information for process-related matters within the transfer team to maximize process understanding and enhance knowledge-based decision making.
Draft and provide ownership of manufacturing documentation (assessments, procedures, batch records, training materials, specifications, etc.). This function involves creating, revising, and withdrawing documentation, including ownership of related compliance actions.
Establish and maintain knowledge on the relationship between the process, the equipment, and the automation in the facility specifically related to the new process being transferred. Ensure that equipment works to its specification and capacity. Coordinate with local area SMEs to ensure historical knowledge and equipment understanding is applied to the process being transferred.
Provide leadership and ownership of all assigned actions/deliverables within assigned projects. When needed, lead team meetings, track metrics and project statuses, escalate urgent matters, and ensure the cross-functional team is fully engaged. Provide input during action review sessions and provide recommendations for improvement projects based on key performance indicators and observed trends.
Assist with investigations related to product and process including complaints, out of expectation, out of specification, etc.
Complete source documents and regulatory sections for new and updated filings, as well as, provide SME responses to market authority questions through approval of tech transfer.
- Ensure protocols are executed as intended by providing Associate training and on the floor start to finish execution support of protocols
- Support execution of process validations and PPQ execution
- Liaising with manufacturing, shop floor QA, and maintenance to ensure accurate process execution and resolution when needed
- Bachelor’s degree required. Degree in an engineering or science discipline such as biochemistry or molecular biology preferred.
- Minimum 3+ years related industry experience required; 5+ years experience preferred including 3+ years’ experience in pharmaceutical/biotech operations in a technical role.
- Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) and working in clean room environments preferred.
- Background/experience in biochemistry or molecular biology preferred and experience with SAM technology is highly desirable.