Job Purpose:

This person will be a member of the Manufacturing Sciences & Technology team at the Holly Springs Influenza Vaccine manufacturing facility, supporting Viral Pilot Plant (VPP) operations.  The person will independently provide the technical and operation skill-sets necessary to manufacture high quality biological material and to meet safety in a compliant, efficient, and cost-effective manner at Seqirus Holly Spring.

This position has responsibilities that include providing technical expertise related to the process, equipment, and business systems that drive manufacturing and strategic improvements of 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.

Minimum Qualifications:

• Minimum of 1 year experience in pharmaceutical/biotech operations working in a technical role.
• 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.
• 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. 

Education:

Bachelor’s degree required.

Degree in Engineering or Science discipline preferred.

Our Benefits

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