AddressThe company is a well-established leader in the field of nuclear science and technology based in South Sydney.
About the Role:
Evolve Scientific is seeking an experienced Sterility Assurance and Microbiology Specialist for our clients sterile manufacturing facility. Experience and a proven track record in sterile manufacturing with a strong testing focus is essential.
This organisation is expanding into the global market and so strict external regulatory requirements must be adhered to including TGA, FDA, ISO 9001, ARPANSA and ASNO.
Duties:
- Subject matter expert for Sterility Assurance function for Nuclear Medicine business
- Lead Sterility Assurance related investigations and risk assessments
- Lead Sterility Assurance continuous improvement initiatives
- Lead Sterility Assurance related validations including process simulation media fill, equipment qualification and facility certifications
- Monitor and report on Sterility Assurance metrics and trends
- Lead Sterility Assurance education programs across the Nuclear Medicine business
- Oversee transition to revised PIC/s Code to GMP Annex 1
- Qualifications in Microbiology or related discipline essential
- Experience in a sterile/GMP pharmaceutical manufacturing facility
- Experience with aseptic processing, cleaning validation, sterile principles and Microbiology
- Sound knowledge in TGA/FDA and other relevant regulatory bodies
- Excellent interpersonal and communication skills
Generous salary and career growth opportunities on offer for the right candidate. As a requirement, you must hold Australian Citizenship to apply for the role as this is within a Government department.
Applicants will need to complete a pre-employment medical and security clearance.
- Training, development and mentoring opportunities
- Performance based salary increases
- Work-life balance with generous leave entitlements and flexible conditions
Click on the "Apply Now" button with a cover letter addressing the selection criteria above AND a detailed resume in WORD format (PDFs can be corrupted / not processed).
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.
