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 the second largest influenza vaccine company 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!

The Role

We are seeking an Senior Engineering Compliance Associate to join the Engineering Capital Projects team based in Parkville (Australia). Reporting to the Engineering Systems Compliance Manager, this full time permanent role will support, drive and report on GxP, EHSS and other compliance activities within the Engineering Function. This interesting and varied role will also collaborate on strategic direction to improve compliance and act as proxy for the departmental lead when required. Specifically this role will:

• Participate and conduct (both, safety and GMP) internal and external audit-processes including scheduling, completing and reporting;
• Coordinate the Engineering Compliance Registry to include - training SMEs, audit schedules;
• Coordinate the Engineering Audit-Readiness package;
• Monitor incident and CAPA management and support stakeholders to complete related activities in a timely manner and sharing learning;

• Provide support in relation to Engineering Compliance at the Woodend site;
• Participate in GEMBA walks to assess risks on ad hoc tasks
• Facilitate project governance/ Stage Gate Methodology global harmonisation activities;
• Manage the engineering compliance related activities of one direct report;
• Generate status reports on general engineering systems compliance
• Perform scheduling duties for the Eng. Department (1 day/wk).

To be considered for this role, you will require:

• Bachelor's degree in Engineering or Construction preferred; Technical experience in pharmaceutical or regulated industry may be considered in lieu of an Engineering degree;
• 2+ years experience implementing compliance in a manufacturing environment;
• Experience in Analysis and project-definition;
• Experience in communicating effectively with with customers, design teams, contractors, and management;
• Demonstrated skills in problem solving, technical learning, time management and prioritizing;
• Knowledge and understanding of regulatory/compliance codes with regard to manufacturing and engineering (GMP, GLP, GEP, ISO 9002, OH&S, TGA, FDA, etc);
• Action oriented skills and ability to learn on the fly;
• MS office advanced level;

How to apply

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-139761

Applications will close on 24 September 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 .

Worker Type:
Employee

Worker Sub Type:
Regular