Sterility Assurance Specialist (Melbourne)

Sterility Assurance Specialist (Melbourne)

06 Aug
|
Synergie
|
Melbourne

06 Aug

Synergie

Melbourne

Sterility Assurance professional overseeing environmental monitoring, contamination control, compliance, and investigations.

Synergie Australia is seeking an Associate Sterility Assurance Specialist for a trusted client located in Broadmeadows.

Position Details

Date of publication

24/07/2026

Location

Melbourne - North, VIC

Industry

Science

Salary/Pay

Not disclosed

Reference number

- Pay: Competitive hourly rate + Super | Duration: 12-month contract
- Hours: Monday-Friday | Standard business hours (approx. 8:00am-4:00pm) | 38 hrs per week | Hybrid arrangement (3 days onsite, 2 days WFH)

What you will be required to do:

You’ll play a key role within the Sterility Assurance team, supporting the oversight and lifecycle management of sterility assurance monitoring controls at a leading pharmaceutical manufacturing site. This role combines technical microbiology expertise, data trending, quality oversight and stakeholder engagement.

- Supporting Environmental Monitoring (EM) and Personnel Monitoring programs across manufacturing facilities
- Reviewing and analysing viable and non-viable monitoring data and identifying emerging trends
- Supporting sterility assurance investigations, deviations, CAPAs and contamination control initiatives
- Assisting with validation and qualification activities for facilities, utilities, equipment, personnel and microbiological methods
- Preparing and reviewing trend reports, risk assessments, SOPs, protocols and quality documentation




- Providing quality oversight for sterility assurance systems and compliance activities
- Partnering closely with Operations, Manufacturing, Engineering, Validation, QA and QC teams
- Supporting continuous improvement initiatives and maintaining compliance with GMP and regulatory requirements

To be successful in the role you will:

- Bachelor's degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science or a related scientific discipline
- 3-5 years' experience within Sterility Assurance, Environmental Monitoring, QC Microbiology, QA or a related pharmaceutical manufacturing role
- Experience working within GMP-regulated pharmaceutical manufacturing environments
- Strong understanding of Environmental Monitoring, contamination control and sterility assurance principles
- Experience with data trending, Excel reporting and investigation of trend increases or monitoring excursions
- Excellent communication and stakeholder management skills
- Strong problem-solving, root cause analysis and investigation skills
- Experience supporting aseptic manufacturing environments will be highly regarded

What’s on offer for you:

- Opportunity to join a global leader in pharmaceutical manufacturing
- Exposure to key sterility assurance and contamination control programs
- Significant stakeholder engagement and site ownership opportunities
- Collaborative and supportive team environment
- Hybrid working arrangement available
- Potential for long-term growth opportunities and development within the organisation

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📌 Sterility Assurance Specialist (Melbourne)
🏢 Synergie
📍 Melbourne

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