Validation Manager

Last updated 11 days ago
Location:Parkville
Job Type:Full Time

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

Located in Parkville (Australia) and part of the Seqirus Global Validation Team, this role is a full-time permanent role. This Validation Manager role is responsible for all aspects of facility and equipment qualification and process and cleaning validation. Responsibility includes improvement of the validation systems to meet global and industry standards. You will also manage all aspects of validation projects to support changes to existing plant, equipment and processes for the Seqirus Australia business.

Working with colleagues around the global Seqirus network to establish best practice validation procedures, specific responsibilities in this dynamic role will include:

  • Sound knowledge of cGMP and relevant industry guidance documents and standards; ISO and EN, with a good understanding of validation principles.
  • Validation responsibilities such as cleaning and sterilization, classified space environmental qualification, and Stage 2 Process Validation;
  • Proactively developing or seeks support to develop solutions to complex and strategic issues and develops effective contingency plans
  • Working effectively with key business functions to ensure all site facilities, systems and processes remain in a validated state;

To be considered for this role, you must possess:

  • Bachelor’s degree in Engineering, technical or science related field, and post graduate qualifications will be highly regarded;
  • Minimum 5 years demonstrated management experience leading a technical team in the pharmaceutical regulated industry.
  • Experience in sterile drug pharmaceutical industry desirable
  • Experience in Project Management desirable
  • Demonstrated ability of effectively working cross-functionally and with a wide range of seniority is desirable.
  • Demonstrated working knowledge of validation principles and cGMPs, FDA regulatory guidelines, including interaction with regulators;
  • Well developed analytical and problem solving skills;
  • Exceptional interpersonal and communication skills including collaborating, influencing, negotiating and presenting.

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-124163

Applications will close on Friday 30th October 2020

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.