Tissue Processing Operator

About Anteris® Technologies

Anteris® Technologies is an international structural heart company headquartered in Minneapolis, MN, US, with additional locations in Geneva, Switzerland, and cities across Australia including Brisbane and Perth. Our company is committed to revolutionizing cardiac care by developing innovative science-based solutions aimed at restoring healthy heart valve function. We focus on advancing transcatheter aortic valve replacement (TAVR) devices beyond their original use for older, high-risk patients to benefit younger, more active individuals. Our flagship product, the DurAVR® THV, integrates proprietary ADAPT® anti-calcification technology designed to emulate the function of a natural heart valve.

Role Overview

Based in our Malaga facility, the Tissue Processing Operator will manage the receipt, examination, cleaning, and processing of raw animal pericardium to an ethanol-treated intermediate condition, preparing it for subsequent manufacturing stages. Operations will strictly adhere to GMP, ISO 13485, and internal manufacturing guidelines.

Primary Responsibilities

• Accept raw pericardium shipments from approved abattoirs, ensuring complete chain-of-custody and documentation verification.
• Conduct meticulous visual inspections to assess quality, identify any damages, contamination, or deviations from standard.
• Execute trimming, washing, and initial cleaning procedures following standard operating procedures (SOPs) and documented batch records.
• Prepare chemical baths including ethanol and saline solutions and carry out processing steps as per validated protocols.
• Manage timing, agitation, transfer, and storage activities according to validated work instructions, ensuring batch segregation to prevent cross-contamination.
• Support downstream manufacturing processes as needed.
• Accurately complete batch manufacturing records contemporaneously, reporting lot numbers, waste, deviations, yield data, and environmental conditions.
• Maintain thorough traceability for all pericardium processing stages.
• Work within controlled environments such as cleanrooms, following correct gowning and behavioral protocols.
• Perform routine cleaning, sanitization, and functional checks of equipment daily.
• Identify and report non-conformities promptly by raising deviations.
• Comply fully with ISO 13485 and internal quality management system (QMS) requirements.
• Complete mandatory GMP and role-specific training annually and maintain up-to-date training records.
• Operate relevant processing tools and equipment safely while adhering to workplace health and safety (WHS) and safety data sheet (SDS) regulations for chemical handling.
• Maintain cleanliness and organization of processing areas.

Qualifications & Experience

• Certificate III or IV in Laboratory Techniques, Biological Sciences, Animal Science, or Medical Device Manufacturing preferred, or equivalent practical experience.
• Knowledge of laboratory practices with familiarity or experience in GMP, ISO 13485, or regulated manufacturing environments advantageous.
• Strong aptitude for following SOPs and precise record-keeping abilities.
• High levels of attention to detail and commitment to traceability standards.
• Experience in collaborative, multidisciplinary team environments is a plus.
• Competence in Microsoft Office software applications.
• Excellent communication and interpersonal skills.
• Ability to work within laboratory or cleanroom settings requiring personal protective equipment (PPE) and gowning.
• Comfort and capability in handling animal tissues and chemicals such as ethanol.

What You Can Expect

• The opportunity to significantly influence patient care by contributing to groundbreaking cardiac therapies.
• A collaborative and innovative workplace culture that values excellence.
• Membership of a growing organization that values team contributions.

Compensation and Additional Information

The position follows the national market pay scale with an hourly wage range of 30 to 31 Australian Dollars (AUD).

Note: Candidates may be required to provide proof of COVID-19 vaccination to comply with relevant health and safety regulations.

Diversity and Inclusion

Anteris Technologies proudly fosters diversity, multiculturalism, and inclusion as integral parts of our mission. We recruit, develop, and promote individuals regardless of race, religion, sex, disability, age, veteran status, or other protected statuses, endorsing a culture of belonging.