Process Validation Associate Location: Sydney Work Type: 12-month fixed-term contract, Full-Time About us: SpeeDx is a dynamic company with a strong portfolio of technology at the cutting edge of molecular diagnostics. Our team in offices and laboratories in Sydney, London, and Austin, work together in an innovative, challenging, and collaborative environment, towards our critical mission of developing clinically relevant tools to positively impact healthcare networks around the world. At SpeeDx, we are passionate about improving patient outcomes; specializing in molecular diagnostic solutions that go beyond simple detection to offer comprehensive information for improved patient management. Our technology supports clinical diagnostic products for infectious diseases with a range of products in the market and a pipeline of research and In Vitro Diagnostic (IVD) assays since 2009. SpeeDx believes our employees are pivotal to our success and reputation, therefore we strive to offer true work/life balance with opportunity structured career development. We are committed to recruiting, developing, and retaining the best and diverse talent. If you would like to work for a company that was awarded 2021 Australian Company of the Year at the AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards, please apply now. About the Role: • 12-month fixed term contract as a Process Validation Associate • Suitable step-up role from Assistant level • This role will report to the Senior RA & QA Manager. • This role will be based in Redfern, Monday-Friday. • Training provided to ensure smooth transition to the role and the company • Opportunity to grow your career in a Molecular Diagnostic company for the right candidate • Working in an ISO 13485 accredited manufacturing environment • Supporting validation activities related to manufacturing processes, equipment, and quality system to ensure compliance with regulatory standards. • Maintaining product quality, consistency, and regulatory compliance through process validation, verification, and stability studies. Your primary responsibilities will involve but not limited to: • Plan, execute, and document validation activities for manufacturing processes, including process performance qualification (PPQ). • Prepare verification and validation protocols and reports, ensuring compliance with internal and regulatory requirements (e.g., ISO 13485, MDSAP, TGA). • Coordinate and conduct process and test method validation with key stakeholders. • Analyse and interpret validation data, identifying trends, deviations, or potential issues. • Conduct risk assessments and process capability studies to support validation strategies. • Communicate and present validation results to the project team or key stakeholders. • Perform and monitor real-time stability testing to assess the impact of storage conditions on product integrity. • Collect and analyse stability data to determine product shelf life and compliance with specifications. • Maintain documentation for stability studies, ensuring traceability and alignment with regulatory guidelines. • Conduct or participate in validating and maintaining manufacturing equipment, ensuring proper installation, operation, and performance qualification (IQ/OQ/PQ). • Review applicable equipment maintenance schedules and perform calibration, preventative maintenance, and liaise with external suppliers. • Maintain clear and accurate documentation, ensuring compliance with Good Documentation Practices (GDP). Person Specification Qualification & Experiences Essential/ Desirable Bachelor’s degree in science, engineering, biotechnology, or a related field E Minimum of 1 year of experience in validation, process engineering, or quality assurance within the medical device, diagnostics, or pharmaceutical industry. E Experience with real-time stability testing and shelf-life determination. D Experience working in an ISO 13485-certified or GMP-compliant environment. D Knowledge of CAPA processes and continuous improvement initiatives. D Technical Knowledge Understanding of process validation principles (ISO 13485, FDA, GMP) E Experience with analytical techniques such as PCR, spectrophotometry, HPLC, or ELISA. E Familiarity with risk assessment methodologies and statistical analysis for validation activities. E Knowledge of equipment qualification (IQ/OQ/PQ) and stability studies. D Skills Strong analytical and problem-solving skills. E Excellent attention to detail and accuracy in documentation. E Effective written and verbal communication skills. E Ability to work independently and collaboratively in a cross-functional team. E Strong organizational skills with the ability to manage multiple projects simultaneously. E Understanding of statistical analysis for validation and trend analysis. D Familiarity with regulatory submissions and audits. D Previous experience working with automated validation software or data management systems. D To apply for this opportunity, please email your CV and accompanying cover letter and include in the subject the job title: Process Validation Associate to: hrspeedx.com.au Please note, only shortlisted candidates will be contacted. SpeeDx will only retain unsuccessful applications for up to 12 months for future reference, unless advised otherwise.