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!
Work as a member of a team to install, qualify and maintain Quality Control laboratory instrumentation per regulatory guidelines.
Ensure laboratory instruments/equipment are qualified, calibrated, maintained. Perform or supervise as necessary. Complete and/or review associated documentation complying with cGMP standards.
Coordinate and perform installation of new instruments. Develop and execute Installation Qualification and Operational Qualification procedures for instruments. Develop and execute associated protocols.
Develop and execute: Instrument Operating Procedures.
Develop and execute: Change Controls, CAPA’s, Risk Assessments, and instrument investigations.
Maintain working knowledge of regulations and guidelines as related to laboratory instrumentation (USP, 21CFR Part 11, ISO, ASTM).
Coordinate qualification, maintenance and repair of equipment by outside vendors. Review of documentation. Manage instrument schedules accordingly. Participate in cross-departmental teams as required.
Participate in regulatory audits.
Work with internal departments including: Metrology, Maintenance, Engineering, Critical Systems, I&T.
Coordinate any other duties/responsibilities assigned by senior management.
Education: BS/BA degree in Science field (Chemistry preferred)
Experience: Minimum of 3-5 years of using laboratory instruments, instrumentation repair/qualification experience preferred.
Competencies: Ability to work independently and as part of a team, Communication skills, Organizational skills, computer skills, knowledge of laboratory instrumentation and techniques, technical writing and repair experience preferred. Experience with STARLIMS & SAP preferred.