Engineer I/ II/ III (MS&T) Viral Pilot Plant
With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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 key shop floor member in manufacturing sciences and technology (MS&T) Viral Pilot Plant (VPP) organization. The incumbent will independently provide the technical and operation skill-sets necessary to manufacture high quality biological clinical trials material and to meet safety in a compliant, efficient, and cost effective manner.
This position will provide technical expertise related to the process, equipment, and business systems that drive strategic improvements within Bulk -Cell Culture. Provide support of production and process-specific issues.
- Responsible for preparing, and sterilizing production equipment
- Authorize SOPs and BPRs
- Execute process steps according to defined SOPs, BPRs
- Document activities and review of documentation in accordance with cGMPs
- Collect and track area metrics and process control data
- Utilize electronic business systems (e.g, PLCs, LIMS, SAP)
- Assist with investigations related to product and process including complaints.
- Follow site biosafety policy to handle biologically and chemically hazardous
- Interface with maintenance, metrology, engineering, and quality
- Enroll new materials, revise existing materials, and update bills of materials
- Serves as a hands-on operator in clinical material production within the Viral Pilot Plant
- Conducts all assigned activities in a safe and cGMP compliant manner
- Bachelor's degree required.
- Degree in an engineering or biological science discipline is preferred.
- Minimum 1 year related industry experience required with BS degree, including experience in biopharmaceutical/biotech operations in a technical role.
- Experience of GMP on commercial or clinical production is strongly preferred
- Experience of biopharmaceutical upstream (cell culture, protein harvest) pilot and/or production scale operation preferred
- Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) and working in clean room environments preferred.