Engineer I/II/III (MS&T) Bulk Manufacturing

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Jan 13, 2022
Ref
R-148120
Required Education
Bachelors Degree
Position Type
Full time
Job Description

Job Purpose:

The incumbent will be a member of the Manufacturing Sciences & Technology team at the Holly Springs Influenza Vaccine manufacturing facility and will be a contributing member of a cross-functional team of SME and Area Leaders specific Bulk production in a commercial manufacturing operation.   The MS&T organization at Holly Springs provides strategic technical direction to manufacturing organizations to achieve supply targets and maximize capacity. This position has responsibilities that include providing technical expertise related to the process, equipment, and business systems to drive strategic improvements. Additionally, this role provides front line support of production and process-specific issues.


Major Accountabilities:

• Provides support and guidance to the Bulk Commercial Manufacturing Operation

• Review/track performance metrics and project statuses.

• Primary point of contact for technical and operational equipment/process within the purification manufacturing space.

• Monitor and/or establish process and operational KPI’s and report on suite metrics

  • Identify and implement continuous improvement projects to improve yield, reliability, process

robustness, and safety.

• Troubleshoot and investigate equipment and process issues within the manufacturing facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence.

• Provide technical information, training, and coaching for process-related matters within production to

maximize process understanding and enhance knowledge-based decision-making.

• Provide ownership of manufacturing documentation (procedures, batch records, training materials, 

etc.).

• Create, Revise, and Withdraw documentation, including ownership of related CAPAs.

• Identify and implement continuous improvement projects to improve yield, reliability, process

robustness, and safety.

• Lead after action review sessions and provide recommendations for improvement projects.

• Develop and encourage an inspiring team environment with an open communication culture

Minimum requirements:
  • Bachelor’s degree required.  Degree in an engineering or science discipline preferred.              
  • Minimum 3 years of related pharmaceutical/Biotech industry experience required, including a minimum 2+ years’ experience in aseptic filling. 5+ years of experience preferred.
  • Proven work experience as a team leader or supervisor with strong organizational, time-management, and decision-making skills
  • In-depth knowledge of performance metrics and statistical process control
  • Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) and working in clean room environments.
  • Knowledge of automation and GMP documentation.
  • Ability to lead a Project to successful completion.
  • Strong Process improvement experience, certification in Lean/Six Sigma preferred

About Us

Our Benefits

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 Seqirus.

About Seqirus

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

We want Seqirus to reflect the world around us

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

Do work that matters at Seqirus!