Sterility Assurance Specialist

Sterility Assurance Specialist

Temporary 67500 - 82500 $ / year (est.) Hybrid
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At a Glance

  • Tasks: Ensure sterility standards in a dynamic pharmaceutical environment and drive continuous improvement.
  • Company: Global pharmaceutical company based in Melbourne's northern suburbs.
  • Benefits: 12-month casual contract, hybrid work model, and normal business hours.
  • Other info: Collaborative culture with opportunities for professional growth and development.
  • Why this job: Join a team making a real impact on health and safety in the pharmaceutical industry.
  • Qualifications: Tertiary education in Microbiology or related field and experience in aseptic manufacturing.

The predicted salary is between 67500 - 82500 $ per year.

About the company/role

Global pharmaceutical company based in Northern suburbs of Melbourne seeking a Sterility Assurance Specialist to join this dynamic team. 12-month casual contract, Monday-Friday, normal business hours. Hybrid role (3 days onsite).

Duties include, but are not limited to:

  • Environmental and personnel monitoring, in-process testing, finished product testing, microbiological method development.
  • Validation and qualification of the facility, utility and equipment, process, personnel and method at the site.
  • Cleaning and disinfection, hygiene, operator training, gowning and behaviour, facility design and process design at the site.
  • Provide expertise to the site related to Sterility Assurance standards, culture and continuous improvement.
  • Partner closely with the global function leads as well as site leadership team, develop strategies to ensure continuous adherence to regulatory and standards related to Sterility assurance governance and drive improvements.
  • Provide QA oversight of quality standards and systems aligned with the Sterility Assurance function in the above areas for the site.
  • Ability to build and maintain strong relationships and collaborate effectively with all levels and cross-functionally within the organisation.
  • Trending & data management, stakeholder management.

Skills/experience required:

  • Tertiary education in Microbiology, Pharmaceutical Science, Biological Sciences or related discipline.
  • Proven experience in a similar role within aseptic manufacturing.
  • Must have a strong background in microbiology or aseptic manufacturing.
  • Experience within pharmaceutical manufacturing is ideal, but open to hospital/medical industry.
  • Excellent written and oral communication skills and strong time management.
  • Experience with Excel and trend analysis.
  • Strong problem-solving skills.

If you think this could be the role for you then please apply now! Please send us a cover letter and a detailed resume in WORD format (PDFs can be corrupted / not processed). Or, if you have any questions, please contact Linda Mork on 9040 1630.

Sterility Assurance Specialist employer: Evolve Scientific Recruitment PTY Ltd

Join a leading plastic manufacturer that values quality and safety in a stable and supportive night shift environment. As a Mechanical Technician, you'll enjoy hands-on maintenance work with opportunities for professional growth and the potential for permanent employment. With a commitment to continuous improvement and a highly regulated facility, this role offers a rewarding experience for those looking to make a meaningful impact in their field.

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Contact Details:

Evolve Scientific Recruitment PTY Ltd Recruitment Team

We think you need these skills to ace Sterility Assurance Specialist

Microbiology
Aseptic Manufacturing
Environmental Monitoring
In-Process Testing
Finished Product Testing
Microbiological Method Development
Validation and Qualification