Snr Associate Quality Engineering

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.

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

Whats 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

Synergie Australia delivers a full 360º recruitment solution consisting of temporary and permanent recruitment services and more. Safety is of the highest priority and Synergie Australia prides itself on fostering a culture that champions guidance and care in the workforce. Beyond recruitment Synergie Australia is motivated to improve everyday standards within the working landscape so people can thrive today and in the future. This approach delivers real change to communities by improving workplaces local economies inequalities and changes to the climate. If you aspire for better lets work together.

If youre ready click apply now or contact our branch on.

Synergie Australia connects people with safe rewarding work across Australia. From temporary roles to permanent opportunities we support you at every stage of your career. Learn more and view current opportunities at