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Job: Engineer II/III, Technical Services Fill Finish Operations, Seqirus, Holly Springs, NC

General Information


Job title:
Engineer II/III, Technical Services Fill Finish Operations
Job location:
Holly Springs, NC  27540 United States
Requisition code:
R-130731
Date posted:
06/09/2021
Compensation:
Job category:
Engineering
Employment type:
Full time

Job Description


Come join a company that tackles fascinating problems and find solutions to complex challenges. With deep expertise in influenza science, our team works on cutting-edge research, pioneering technologies to optimise the manufacturing process and improve the effectiveness of influenza vaccines. We operate as one integrated global organisation, drawing together expert staff from different countries to collaborate. Together, we are working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

Job Summary:

The incumbent will be a member of the Manufacturing Sciences & Technology team at the Holly Springs Influenza Vaccine manufacturing facility and will be responsible for leading a cross-functional team of SME and Area Leaders specific to formulation and adjuvant production in the 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. 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 leadership, support and guidance to the Formulation and Adjuvant Commercial Manufacturing Suite Team
Lead weekly team meetings, track metrics and project statuses, escalate urgent matters, and ensure the cross-functional team is fully engaged.
Primary point of contact for technical and operational equipment/process within the formulation and adjuvant manufacturing space.
Monitor and/or establish process and operational KPI’s and report on suite metrics
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 Withdrawing 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
Effectively delegate tasks and establish deadlines

Job Requirements


Seqirus USA - NC - Holly Springs
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Come join a company that tackles fascinating problems and find solutions to complex challenges. With deep expertise in influenza science, our team works on cutting-edge research, pioneering technologies to optimise the manufacturing process and improve the effectiveness of influenza vaccines. We operate as one integrated global organisation, drawing together expert staff from different countries to collaborate. Together, we are working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

Job Summary:

The incumbent will be a member of the Manufacturing Sciences & Technology team at the Holly Springs Influenza Vaccine manufacturing facility and will be responsible for leading a cross-functional team of SME and Area Leaders specific to formulation and adjuvant production in the 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. 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 leadership, support and guidance to the Formulation and Adjuvant Commercial Manufacturing Suite Team
Lead weekly team meetings, track metrics and project statuses, escalate urgent matters, and ensure the cross-functional team is fully engaged.
Primary point of contact for technical and operational equipment/process within the formulation and adjuvant manufacturing space.
Monitor and/or establish process and operational KPI’s and report on suite metrics
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 Withdrawing 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
Effectively delegate tasks and establish deadlines

Minimum Qualifications:
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
(Job number: 4048464)
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