Senior Associate, Quality Engineering

Evolve Scientific; City of Melbourne; On-site; AUD 90,000 - 120,000; Full time

Job summary

Evolve Scientific in Melbourne is seeking a Senior Associate, Quality Engineering to join the Engineering and Quality team on a 12-month contract. You will support QA across engineering, commissioning, qualification and validation, ensuring GMP compliance and quality standards are met.

The successful candidate will review documentation, escalate issues when needed, and collaborate with project stakeholders to drive compliant outcomes.

Qualifications

• Degree in Life Sciences, Pharmaceutical science or Engineering; advanced degree valued.
• Minimum 3 years in a Quality Engineering role within the pharmaceutical industry.
• Strong QA knowledge, GMP compliance and quality systems.

Responsibilities

• Review and approve engineering documentation.
• Review commissioning, qualification, validation and stability documentation.
• Provide quality oversight during qualification activities.
• Escalate quality and compliance issues with recommendations.
• Support project teams to meet engineering and quality requirements.
• Ensure GMP and regulatory documentation is compliant.
• Collaborate with Engineering, QA and project stakeholders.

Skills

Quality Assurance

GMP compliance

Documentation review

Problem solving

Education

Life Sciences degree

Pharmaceutical science

Engineering degree

Job description

About the Company

Our client is a leading global biopharmaceutical organisation committed to developing and delivering innovative therapies that improve and save lives worldwide. With a strong focus on quality, compliance and continuous improvement, they operate state-of-the-art manufacturing and quality facilities supporting critical healthcare products. This role is based in Broadmeadows, Melbourne.

About the Role

We are seeking an experienced Senior Associate, Quality Engineering to join a dynamic Engineering and Quality team on an initial 12-month contract. The successful candidate will be responsible for providing quality engineering support across engineering, commissioning, qualification and validation activities, ensuring compliance with GMP and quality requirements while supporting project delivery.

Key Responsibilities

• Review and approve engineering documentation.
• Review commissioning, qualification, validation and stability documentation.
• Provide quality oversight and support throughout qualification activities.
• Escalate quality and compliance issues and provide recommendations on appropriate next steps.
• Support project teams to ensure engineering and quality requirements are met.
• Ensure documentation and processes comply with GMP and regulatory expectations.
• Work collaboratively with Engineering, Quality Assurance and project stakeholders.

Must Have

• Degree in Life Sciences, Pharmaceutical science, Engineering or a related discipline. Advanced degree highly regarded.
• Minimum 3 years' experience in a similar Quality Engineering role within the pharmaceutical industry.
• Previous technical experience in engineering, commissioning and qualification.
• Strong understanding of Quality Assurance, GMP compliance and quality systems.
• Demonstrated independent problem-solving abilities.
• Excellent attention to detail and documentation review skills.