Senior Sterility Assurance Expert

7 days ago


Lucas Heights, Australia Evolve Scientific Full time
About the Role

Evolve Scientific is seeking an experienced Sterility Assurance Specialist to lead our clients’ sterile manufacturing facility in the design and implementation of a new contamination control strategy. The ideal candidate will have a proven track record in sterile contamination control validation and experience in a senior level sterility validation role.

Key Responsibilities
  • Subject matter expert for sterility assurance function
  • Lead investigations, risk assessments and CI initiatives relating to sterility CCS
  • Design and validate equipment across the whole manufacturing facility to meet the PIC/s guidelines
  • Monitor and report on sterility assurance metrics and trends and initiate complex investigations into deviations and CAPAs
  • Lead sterility assurance education programs across the Nuclear Medicine business
  • Oversee transition to revised PIC/s Code to GMP Annex 1
Requirements
  • Tertiary qualifications in science or engineering essential
  • Experience in a sterile/GMP pharmaceutical manufacturing facility
  • Experience in contamination control and its design and implementation
  • Strong knowledge in TGA/PIC/s and other relevant regulatory bodies
  • Excellent interpersonal and communication skills
Benefits
  • Band 6 - $107-124K + 15.4% salary
  • Parking, childcare, gym, swimming pool, café on site
  • Permanent government role
  • Training, development and mentoring opportunities
  • Performance based salary increases
  • Work-life balance with generous leave entitlements and flexible conditions

Please send a cover letter and detailed resume in WORD format to apply.



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