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: 210086592
Senior Associate, Quality Engineering | Broadmeadows
Synergie Australia is seeking a Senior Associate, Quality Engineering for a trusted global pharmaceutical client located in Broadmeadows.
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.
The important 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
- Collaborative 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
Snr Associate – Quality Engineering in Melbourne employer: Synergie
Synergie is an excellent employer that prioritises the safety and well-being of its employees while fostering a collaborative work culture. With a focus on professional development, employees have access to growth opportunities and training programs that enhance their skills in maintenance and plant reliability. Located in Melbourne's vibrant south-eastern suburbs, the company offers a supportive environment where teamwork and innovation thrive, making it an ideal place for those seeking meaningful and rewarding employment.
