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MS&T Engineer I/II - Tech Services

Location
Holly Springs, North Carolina
Job Type
Permanent
Posted
15 Jan 2023

The Opportunity

You will be a member of the Manufacturing Sciences & Technology (MS&T) Technical Services team at the Holly Springs Cell-based Influenza Vaccine manufacturing facility and will join a team of Scientists and Engineers focused on Drug Product production in a commercial Fill Finish Manufacturing operation. The MS&T organization at Holly Springs provides strategic technical direction to manufacturing organizations to achieve supply targets and maximize capacity. Specifically, the MS&T Technical Services team provides expertise related to the product and process to ensure continuity in manufacture. As subject matter experts of the process, the team will use quality systems to lead important process deviations to support batch release and ensure detailed implementation of process improvements. Members will report to the MS&T Drug Product Tech Services Manager but are encouraged to work within the larger MS&T organization to build process understanding and develop valuable competencies.

The Role

  • Provide technical leadership to the Fill Finish Manufacturing Operations team.
  • Primary contact for operational product and process related issues within either the formulation, filling or packaging manufacturing areas.
  • Responsible for process characterization, continuous process verification, data monitoring, and performance metrics necessary to implement continuous improvement projects to improve yield, efficiency, process robustness, and product quality.
  • Author and maintain process documents necessary for investigations, process design, technical studies, and implementation of new materials.
  • Solve process-related issues within the manufacturing facility, coordinating with appropriate teams to resolve problems and prevent recurrence.
  • Provide technical training within production to maximize process understanding and enhance knowledge-based decision-making.
  • Provide ownership of supporting manufacturing process documentation (process descriptions, parameter risk assessments, specifications, and sampling plans).
  • Facilitate cross-functional team discussions providing recommendations for improvement projects
  • Develop and encourage an inspiring team environment within the company culture.

Your skills and experience

Level of role determined by related industry experience (pharmaceutical/biotech operations preferred).

  • Bachelor's degree required. Degree in Engineering or Science discipline.
  • Level of role determined by related industry experience (pharmaceutical/biotech operations preferred)
  • Understanding of basic engineering or scientific principles

Skills

  • Displays understanding of basic engineering and scientific principles.
  • Troubleshooting experience
  • Technical writing skills
  • Organizational planner
  • Comfortable in both a team and autonomous setting

Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.

Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join CSL Seqirus.

About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus .

We want CSL Seqirus to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.

Do work that matters at CSL Seqirus!

Watch our On the Front Line' video to learn more about CSL Seqirus

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Details

  • Job Reference: 876460413-2
  • Date Posted: 15 January 2023
  • Recruiter: Seqirus
  • Location: Holly Springs, North Carolina
  • Salary: On Application
  • Sector: Manufacturing Operations
  • Job Type: Permanent