Specialist II/III, (Validation)
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!
Responsible for validation lifecycle activities for equipment and computer systems, primarily within the Fill Finish, Quality Control, and Utility areas of the facility.Major Accountabilities:
Works independently to qualify multiple types of GMP systems (e.g., utilities, facilities, lab instruments, computer systems, autoclave, parts washer, filler, isolator, and packaging systems).
Utilizes SOPs to develop validation protocols and summary reports.
Executes protocols and collects samples in support of validation studies.
Coordinates, plans, and executes work including new facilities or complicated changes.
Ensure that current industry standards and reviewed and implemented. May be CQV lead for major projects (e.g., new buildings) or validation subjects within the facility.
Analyzes data using statistical analysis tools. Interprets results vs. acceptance criteria and regulatory guidance.
Leads major deviation investigations utilizing root cause analysis and investigation tools. Owns corrective/preventative actions.
Participates in audits as subject matter expert in area of responsibility.
Programs and calibrates temperature monitoring equipment (Kaye Validator, Lives loggers) for use in qualification protocols.
Provides training to new/junior team members.
Bachelor degree required. Engineering, Mathematics or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.) preferred.
Minimum of 3 years of quality systems/validation experience in pharmaceutical manufacturing/a highly regulated industry
Knowledge of current Good Manufacturing Practices (cGMP)
Knowledge of FDA and EMA requirements