Job Description
Senior Quality Engineering role supporting GMP compliance, validation projects.
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Position Details
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Date of publication: 16/07/2026
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Location: Melbourne - North, VIC
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Industry: Science
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Salary/Pay: Not disclosed
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Reference number: *********
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Senior Associate, Quality Engineering | Broadmeadows
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Synergie Australia is seeking a Senior Associate, Quality Engineering for a trusted global pharmaceutical client located in Broadmeadows.
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We think outside the box by redefining recruitment. Through long-term partnerships, we connect the right people (You) with the right opportunities to shape careers and drive change in Australia and beyond.
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The important parts:
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Pay: Competitive hourly rate + Super
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Duration: 12-month contract with potential for extension
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Hours: Monday-Friday | Standard business hours | 38 hours per week
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Location: Broadmeadows | Predominantly onsite with some flexibility to work from home when required
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What you will be required to do:
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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.
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Review and approve engineering, commissioning and qualification documentation
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Provide quality oversight for GMP-compliant commissioning and qualification (C&Q;) activities
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Review and approve validation protocols and reports, including process, cleaning and filter validation
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Support technology transfer, method transfer and stability programs
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Participate in quality risk assessments and project stage gate reviews
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Manage quality aspects of change controls,
deviations and investigations related to engineering activities
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Support regulatory inspections, submissions and audit readiness activities
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Ensure Engineering standards, SOPs and quality systems comply with internal and regulatory requirements
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Partner closely with Engineering, Validation and cross-functional project teams
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Provide guidance and escalation support during qualification and project execution activities
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To be successful in the role you will:
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Hold a degree in Life Sciences, Engineering or a related discipline
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Have 3+ years' experience in a Quality Engineering, Quality Assurance or similar role within the pharmaceutical industry
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Demonstrate strong knowledge of GMP, GxP, FDA and EU regulatory requirements
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Have previous experience in commissioning and qualification, validation and quality oversight activities
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Possess strong problem-solving skills and the ability to make risk-based decisions independently
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Have experience reviewing and approving technical and quality documentation
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Demonstrate excellent communication and stakeholder management skills
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Maintain a high level of attention to detail and commitment to compliance
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Engineering experience and/or a sterility assurance background will be highly regarded
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What's on offer for you:
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Opportunity to join a global leader in the biotechnology and pharmaceutical industry
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Exposure to high-profile CAPEX and OPEX projects within a GMP manufacturing environment
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Collaborative and supportive team culture
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12-month contract with strong potential for extension
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Opportunity to further develop your expertise in Quality Engineering, Validation and Regulatory Compliance
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Adaptable working arrangements available from time to time
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Broadmeadows location with modern manufacturing facilities
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