Specialist II/III, (Validation)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Sep 27, 2021
Ref
R-145329
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:
 

Reporting to the Manager of Validation, the Validation Specialist is responsible for validation lifecycle activities for equipment and computer systems using an integrated commissioning and qualification approach. Provides support of validation programs such as cleaning, shipping, computer systems, and aseptic.

*Level will be determined by years of experience

Major Accountabilities:

  • Uses SOPs to develop validation protocols and summary reports.  Executes protocols and collects samples in support of qualification/validation studies.
  • Basic data analysis skills including simple statistical analysis tools and comparison to pre-defined acceptance criteria.
  • Leads simple deviation investigations utilizing root cause analysis and investigation tools. May own corrective/preventative actions.
  • Programs and calibrates temperature monitoring equipment (Kaye Validator, Lives loggers) for use in qualification protocols.
  • Coordinates validation activities with the appropriate system owners and other affected departments. Integrates validation maintenance activities into site schedules.
  • Other job duties that may be assigned from time to time.

Minimum Qualifications:

  • Bachelor’s degree or equivalent.
  • Bachelors degree in Engineering, technical or science related field preferred. 
  • Minimum of 2 years of hands-on commissioning, qualification and/or validation experience OR equivalent required. 
  • Pharmaceutical manufacturing related experience preferred.
  • Previous experience with an integrated qualification approach preferred.