About CSL

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

We are currently seeking an experienced Validation Specialist to join the Quality team in Parkville (Australia) to assist in the completion of a project. Reporting to the Equipment Validation Manager, this full-time 6 month fixed term position is responsible for performing validation activities associated with a new piece of equipment and the associated processes for Seqirus Parkville.

Specific responsibilities will include:

• Perform the validation activities associated with the plant and equipment project;
• Perform validation activities in accordance with the Quality Management System, Site Validation Master Plan, Business Improvement and Validation procedures;
• Prepare, implement and maintain departmental documentation for validation activities and regulatory submissions (i.e. Validation protocols and reports, Executive Summaries and Validation Master Files);
• Build and maintain strong collaborative relationships with key stakeholders;
• Participate in internal (e.g. Quality Compliance, Safety and departmental) and external (e.g. TGA, FDA) audits, as requested;
• Ensure all training certification requirements are up-to-date;
• Follow the documented procedures to maintain a safe work environment, assist with EHS Risk Assessments and the implementation of safety improvement initiatives;

The successful candidate must possess:

• A relevant science or engineering tertiary qualifications and demonstrated experience gained in the pharmaceutical industry;
• Good knowledge of cGMP;
• Good knowledge of industry guidance documents and standards,
• Strong verbal and written communication skills;
• Good presentation and interpersonal skills to facilitate collaboration across the business;
• Computer literacy and experience using Microsoft applications and familiarity with SAP eQMS, LIMS (e.g. GLIMS);
• Good time management skills and able to work with multiple tasks and changing priorities

Experience with validation activities required for automated visual inspection will be highly advantageous.

Other Important things to note:

The successful candidate may be required to undertake vaccination against the influenza virus.

If you are looking to develop your skills and shape the health of Australians, please apply with your resume and cover letter, which must address the selection criteria above, and include the reference number R-127954.

Applications will close on January 27, 2021.

CSL advises that screening including; criminal history, medical assessment, confirmation of experience, stated qualifications and other relevant checks form a part of the candidate suitability evaluation process. Where applicable, this applies to current CSL employees. CSL employees must notify their current manager when selected for interview for any advertised internal vacancies .