Senior Associate, Sterility Assurance

We are seeking an experienced Validation SME – Sterility Assurance to join a high-performing Global Quality team. Reporting to the Sterility Assurance Lead, you will provide expert leadership and oversight across contamination control and sterility assurance programs, ensuring compliance with global regulatory standards and driving continuous improvement across manufacturing operations.

This is a critical role supporting sterile manufacturing environments, where your expertise will directly impact product quality, patient safety, and operational excellence.

This is a fixed term contract until June 2027 based at our Broadmeadows site.

Key Responsibilities

Sterility Assurance Leadership

• Lead the lifecycle management of contamination control across facilities, equipment, processes, personnel, and methods

• Develop and implement sterility assurance strategies aligned with global and regulatory standards

• Provide expert guidance to site leadership, engineering, validation, and quality teams

Validation & Compliance

• Oversee validation activities including IQ/OQ/PQ, media fills, EMPQ, cleaning validation, and filter validation

• Ensure compliance with cGMP, FDA, EU, and other global regulatory requirements

• Support regulatory submissions and act as SME during GMP inspections and audits

Operational Excellence

• Drive continuous improvement in aseptic processes, contamination control, and cleanroom practices

• Establish and maintain best-practice sterility assurance systems and documentation

• Support new projects, site expansions, and capacity increases

Collaboration & Stakeholder Management

• Partner with global and site-based teams to ensure consistent standards across manufacturing sites

• Influence and build strong relationships across cross-functional teams

• Champion a knowledge-sharing and learning culture across the organization

About You

You are a quality-focused professional with strong technical expertise and a collaborative mindset, who thrives in a regulated manufacturing environment.

To be successful, you will have:

• 5+ years in pharmaceutical manufacturing, with strong exposure to aseptic processing/sterility assurance

• Proven expertise in cleanroom environments, equipment validation, and contamination control

• Strong background in Quality Assurance and regulatory compliance (GxP, FDA, EU, TGA)

• Experience interacting with regulatory authorities and inspections

• Ideally experience within biologics manufacturing

• Strong leadership and influencing skills across all levels

• Excellent analytical thinking and risk assessment capabilities

• Ability to thrive in complex, cross-functional environments

• High attention to detail and strong documentation review skills

• Effective communication and stakeholder management skills

Why Apply?

• Work within a globally recognized pharmaceutical organization

• Play a key role in ensuring product sterility and patient safety

• Exposure to cutting-edge sterile manufacturing technologies

• Opportunity to drive global standards and continuous improvement initiatives