Sterility Assurance Expert

Posted 19 June 2024
Job type Permanent
Contact NameNatasha Cole

Job description

I am representing an established, global health care provider who is on the search for a Sterility Assurance Expert. You will be an SME responsible for ensuring site policies are in place to meet requirements for contamination control of cleanrooms, manufacturing processes, and products.


This role will offer you:


  • A genuine opportunity to make a difference, being exposed to a variety of development projects which have the potential to save lives
  • A lot of mobility and autonomy in the role, while working with a strong leadership team
  • To act as the Sterility Assurance SME for a state of the art manufacturing facility
  • Competitive salary, stock purchase program, Tuition reimbursement, PTO, 401k match, Medical/Dental/Vision coverage


You will be responsible for:


  • Developing and driving continuous improvement initiatives within the Sterility Assurance program
  • Acting as a sterility assurance SME during audits and inspections
  • Overseeing and managing microbiology laboratory activities - environmental monitoring, microbiology testing, microbial identification
  • Writing and reviewing environmental cleaning protocols to support cleaning practices and authoring SOPs to support continuous improvement and CAPAs
  • Responsible for the training program for cleanroom and contamination control practices


Desirable experience and qualifications:


  • Significant experience with microbiology within an aseptic or sterile manufacturing facility
  • BS degree in Science, concentration in Biology or Microbiology, preferably
  • Significant GMP experience and strong understanding of current regulations for sterility assurance
  • Strong leadership/supervisory experience within a similar environment
  • Experience with regulatory inspections and audits