Sterility Assurance Specialist

About the Role

Our client, a leading organisation in the pharmaceutical and biotechnology industry, is seeking an experienced Sterility Assurance Associate to join its Regional Sterility Assurance team.

Reporting to the Site Lead – Sterility Assurance, you will oversee sterility assurance monitoring controls across the site, ensuring compliance with regulatory requirements, GMP standards and internal quality procedures.

You will work closely with site leadership and global teams, with responsibility for an assigned bulk manufacturing facility. Data management, trend analysis and stakeholder engagement will be key aspects of the role.

Key Responsibilities

Oversee environmental and personnel monitoring, microbiological testing and sterility assurance controls.

Support validation and qualification of facilities, equipment, processes and testing methods.

Provide oversight of cleaning, disinfection, hygiene, gowning and contamination control practices.

Ensure compliance with GMP, regulatory and internal quality standards.

Manage monitoring data, analyse trends and identify opportunities for continuous improvement.

Collaborate with global teams and site stakeholders to maintain and improve sterility assurance standards.

Skills and Experience

Degree in Microbiology or a relevant Science discipline.

Experience in aseptic manufacturing, preferably within the pharmaceutical or biotechnology industry.

Knowledge of Sterility Assurance, Environmental Monitoring, GMP and GDP.

Strong data management, trending and analytical skills.

Excellent communication and stakeholder management skills.

Candidates with a microbiology background and aseptic manufacturing experience are preferred. Relevant candidates from hospital environments may also be considered.

The Opportunity

Join an established team of approximately 11 professionals, with the opportunity to take ownership of an assigned manufacturing facility and work closely with senior stakeholders across the business.

If you have experience in microbiology, aseptic manufacturing or sterility assurance, we would welcome your application.