Technology Transfer Engineer II/III (MS&T)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Jun 10, 2021
Ref
R-134455
Required Education
Bachelors Degree
Position Type
Contract

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!

Job Description

Job Purpose:

Provide technical and process expertise for technical transfer of Seqirus products across a global network of Contract Manufacturing Organizations (CMOs), Research and Development scale as well as intercompany movements. To meet the company’s going demand, this position will be required to ensure on-time execution of processes, continuous improvement in quality, yield and efficiency; performed in compliance to cGMP’s, SOPs, and applicable guidelines.

This position has responsibilities that include providing technical expertise related to the process, equipment, and business systems that drive strategic improvements within Bulk Cell Culture and/or Fill-Finish.

Provide front line support of production and process-specific issues.


Major Accountabilities:

• Provide support to the product transfer team as the primary point of contact
• Define, scope, execute and when needed troubleshoot and investigate issues.
• Provide technical information for process-related matters within the transfer team
• Draft and provide ownership of manufacturing documentation
• Maintain knowledge on the relationship between the process, the equipment, and the
automation in the facility.
• Ensure that equipment and process improvements are assessed and when applicable
applied to CMOs.
• Identify and implement continuous improvement projects to improve yield, reliability,
process robustness, and safety across a global network.
• 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
• Enroll new materials, revise existing materials, and update bills of materials.
• Coordinate with vendors for material enrollments and third-party complaints.

Minimum Qualifications:
  • Bachelor’s Degree in related scientific/engineering field required.
  • Minimum of 3 years related industry manufacturing experience required or equivalent.
  • Experience in pharmaceutical/biotech operations in a technical role preferred.
  • Experience with technical transfer process of products to contract manufacturing partners preferred
  • Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) and working in clean room environments preferred.