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 DetailsDate of publication24/07/2026LocationMelbourne - North, VICIndustryScienceSalary/PayNot disclosedReference numberPay: Competitive hourly rate + Super | Duration: 12-month contractHours: 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 facilitiesReviewing and analysing viable and non-viable monitoring data and identifying emerging trendsSupporting sterility assurance investigations, deviations, CAPAs and contamination control initiativesAssisting with validation and qualification activities for facilities, utilities, equipment, personnel and microbiological methodsPreparing 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 requirementsTo 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 regardedWhat's on offer for you:Prospect 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
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📌 Sterility Assurance Specialist (Melbourne)
🏢 Synergie
📍 Melbourne