Supervisor, Manufacturing (Non- Aseptic Fill Finish and Packaging)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Jul 19, 2021
Ref
R-136071
Required Education
Bachelors Degree
Position Type
Full time

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!

Job Description

Job Purpose:

The incumbent will be a Fill-Finish Operations shop floor supervisor in a Flu Vaccine manufacturing facility.

The Fill Finish Expansion Project is a $140-million expansion of Seqirus’ Holly Springs, NC, manufacturing facility.   The expansion allows Seqirus to increase capacity for formulation, fill, and finish manufacturing of cell-based and adjuvanted influenza vaccines for global markets and will create 120 permanent highly skilled jobs, adding to the current workforce at the site of more than 600 employees.  

During the critical testing period:

  • Position will start on Day shift (M-F) - 8-5pm
  • In 2022, position will move to Night Shift Schedule: 2-2-3; 12 hour shift - off every other weekend off
  • Hours: 6pm -6am

Major Accountabilities:
  • Supervises a staff of shift production personnel to ensure safety, training and quality compliance are prioritized for manufacturing goals by focusing on the following:
  • Hiring, development, training, and performance management of manufacturing staff
  • Manages resources and material requirements to meet production and budget targets
  • Schedules manufacturing activities as well as facilitates the completion of equipment maintenance and validation
  • Utilizes Seqirus business systems (SAP, TrackWise, WebTraining, Delta V, Data Historian) to execute production operations
  • Responsible for correct execution of SOPs and production batch records.  Responsible for initiating deviation investigations and leading shop floor technical problem solving
  • Lead and coach  continuous improvement initiatives
  • Serves as a process expert, technical resource and coach for the production team
  • Supports capital projects (Expansion) and product transfers as required
  • Support Factory Acceptance Testing (FAT), Software Acceptance Testing (SAT), Installation & Operational Qualification (IOQ), and Integrated Process Performance Qualification (PPQ)
  • Support the establishment of start-up initiatives related to authoring, reviewing, approving new documents
  • Establish a new equipment training program.
Minimum Qualifications:
  • Bachelor degree, or equivalent in related field, or equivalent vocational or technical education.
  • Minimum of 5 years of experience required. 8 years of experience preferred.
  • Minimum of 3 years of managerial experience in a pharmaceutical, biotechnology, or biological industry preferred.
  • Demonstrated knowledge of GMPs and FDA requirements is required.
  • Knowledge and experience in formulation, filling, automated inspection, or packaging technologies is preferred.
  • Experience managing a matrix team, or direct management experience is required.
  • Experience with lean manufacturing is preferred (yellow belt or green belt certification).