Senior Quality Engineering role supporting GMP compliance, validation projects.
Position Details
Date of publication: 16/07/2026
Location: Melbourne - North, VIC
Industry: Science
Salary/Pay: Not disclosed
Reference number:
Senior Associate, Quality Engineering | Broadmeadows
Synergie Australia is seeking a Senior Associate, Quality Engineering for a trusted global pharmaceutical client located in Broadmeadows.
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Through long-term partnerships, we connect the right people (You) with the right opportunities to shape careers and drive change in Australia and beyond.
The significant parts:
Pay: Competitive hourly rate + Super
Duration: 12-month contract with potential for extension
Hours: Monday-Friday | Standard business hours | 38 hours per week
Location: Broadmeadows | Predominantly onsite with some flexibility to work from home when required
What you will be required to do:
You will play a key role in providing quality oversight across engineering and manufacturing projects within a highly regulated pharmaceutical environment.
Working alongside Engineering, Validation and Quality teams, you will ensure GMP compliance and support the successful delivery of critical site initiatives.
Review and approve engineering, commissioning and qualification documentation
Provide quality oversight for GMP-compliant commissioning and qualification (C&Q;) activities
Review and approve validation protocols and reports, including process, cleaning and filter validation
Support technology transfer, method transfer and stability programs
Participate in quality risk assessments and project stage gate reviews
Manage quality aspects of change controls,



deviations and investigations related to engineering activities
Support regulatory inspections, submissions and audit readiness activities
Ensure Engineering standards, SOPs and quality systems comply with internal and regulatory requirements
Partner closely with Engineering, Validation and cross-functional project teams
Provide guidance and escalation support during qualification and project execution activities
To be successful in the role you will:
Hold a degree in Life Sciences, Engineering or a related discipline
Have 3+ years' experience in a Quality Engineering, Quality Assurance or similar role within the pharmaceutical industry
Demonstrate strong knowledge of GMP, GxP, FDA and EU regulatory requirements
Have previous experience in commissioning and qualification, validation and quality oversight activities
Possess strong problem-solving skills and the ability to make risk-based decisions independently
Have experience reviewing and approving technical and quality documentation
Demonstrate excellent communication and stakeholder management skills
Maintain a high level of attention to detail and commitment to compliance
Engineering experience and/or a sterility assurance background will be highly regarded
What's on offer for you:
Opportunity to join a global leader in the biotechnology and pharmaceutical industry
Exposure to high-profile CAPEX and OPEX projects within a GMP manufacturing environment
Team-oriented and supportive team culture
12-month contract with strong potential for extension
Opportunity to further develop your expertise in Quality Engineering, Validation and Regulatory Compliance
Flexible working arrangements available from time to time
Broadmeadows location with modern manufacturing facilities
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📌 Snr Associate – Quality Engineering (Melbourne)
🏢 Synergie
📍 Melbourne