Lead high-impact validation projects in a regulated medical device environment
Apply your expertise across HVAC, facilities, purified water and cleanrooms
Join a collaborative Operations team on a six-month contract
About the opportunity
We are seeking an experienced Senior Validation Engineer to support the strategic planning, execution and continuous improvement of qualification and validation activities across the organisation. Working within Operations, you will strengthen validation governance, improve process capability and help ensure practices meet regulatory expectations, internal quality standards and changing business needs.
What you’ll be doing:
Validation leadership
Support the Validation Manager in overseeing validation strategy across equipment, processes, packaging, and software.
Lead selected validation projects, ensuring the development of robust protocols, risk assessments, and validation reports.
Mentor engineers and technicians in validation best practices and validation lifecycle principles.
Quality and continuous improvement
Drive periodic validation reviews to keep activities current, compliant and aligned with process performance and regulatory expectations.
Identify opportunities to improve validation processes, documentation quality and lifecycle management practices.
Lead and support validation-related CAPA actions, ensuring timely, thorough and compliant closure.
Analyse process performance data to identify trends, inefficiencies, emerging risks and opportunities for improvement.
Audit and regulatory compliance
Participate in external audits conducted by regulatory authorities and notified bodies.
Perform gap assessments against regulatory standards, identify validation gaps, and collaborate with QA and process stakeholders to implement corrective actions.
Ensure validation lifecycle activities conform to specifications, internal procedures, and applicable laws, regulations, and safety standards.
What you’ll bring:
A postgraduate qualification in science, biomedical science, biotechnology, engineering or a related discipline.
At least eight years’ relevant experience in medical device or biotechnology manufacturing regulated by ISO 13485 and the FDA.
Strong working knowledge of ISO 13485, ISPE guidance and applicable FDA guidance.
Hands-on experience in equipment and process qualification, software validation and test method validation.
Demonstrated experience with HVAC, facilities, purified water systems and cleanrooms.
Visual inspection validation experience will be highly regarded.
Experience participating in internal and external regulatory audits.
Project management capability and a proactive, results-focused approach.
Excellent written and verbal communication skills, with the ability to influence stakeholders.
Advanced proficiency in Microsoft Word, Excel and PowerPoint.
Strong attention to detail, sound problem-solving skills and the flexibility to work outside normal hours when required.
Apply now:
If you are an accomplished validation professional ready to make an immediate impact in a regulated manufacturing environment, we would like to hear from you. Submit your application through SEEK, including your current résumé and a brief outline of your relevant validation experience.
Working Holiday Visa Holders are encouraged to apply.