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
Robust 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 career growth and development within the organisation
#J-*****-Ljbffr

📌 Sterility Assurance Specialist (Melbourne)
🏢 Synergie
📍 Melbourne