Engineer I/II/III, (MS&T) Viral Pilot Plant
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 Manufacturing Sciences & Technology team at the Holly Springs, NC Influenza Vaccine manufacturing facility, supporting Viral Pilot Plant (VPP) operations. The incumbent will independently provide the technical and operation skill-sets necessary to manufacture high quality biological clinical trial material and to meet safety in a compliant, efficient, and cost-effective manner at Seqirus Holly Springs, NC.
This position has responsibilities that include providing technical expertise related to the process, equipment, and business systems that drive manufacturing and strategic improvements within Cell Culture and purification processes.Major Accountabilities:
- 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.
- Responsible for preparing, and sterilizing production equipment
- Execute process steps according to defined SOPs, BPRs
- Document activities and review of documentation in accordance with cGMPs.
- 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.
- Troubleshoot and investigate process related issues, coordinating with appropriate teams to resolve issues and prevent reoccurrence
- Execute process validations and short-term improvement projects, liaising with all the relevant parties to ensure accurate execution.
- Ensure protocols are executed as intended and oversee execution of protocols.
- Bachelor’s degree required.
- Degree in Engineering or Science discipline preferred.
- Minimum of 1 year experience in pharmaceutical/biotech operations working in a technical role.
- Strong experience and knowledge of pharmaceutical manufacturing processes preferred.
- Experience with formulation and filling operations preferred.
- Experience with purification techniques such as ultrafiltration, column chromatography,
- Experience with cell culture and centrifugation
- Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required, with direct experience supporting biannual or pre-approval inspections.
- Must have strong communication skills and high attention to detail.
- Must be flexible, able to multi-task in a fast-paced environment and operate well in a team setting.
- A solid understanding of engineering and/or scientific principles and the ability to apply knowledge.
- Advanced troubleshooting skills with ability to mentor others.
- Excellent organizational, planning and time management skills.
- The ability to work effectively in both a team environment and an individual contributor role.