Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world's first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti-calcification technology, is designed to mimic the natural function of a healthy heart valve.

Located in our Malaga office, the Tissue Processing Operator will receive, inspect, clean, and process raw animal pericardium into an intermediate ethanol-treated state suitable for further downstream manufacturing, in accordance with GMP, ISO 13485, and internal company procedures. At Anteris® Technologies, you'll join a team committed to improving the lives of patients with aortic stenosis through groundbreaking structural heart solutions. This is an opportunity to make a measurable impact on patient outcomes while shaping the future of heart valve innovation.

Key Responsibilities

Raw Material Handling

• Receive raw pericardium from approved abattoirs and verify chain-of-custody and documentation.
• Visually inspect material for quality, damage, contamination, or deviations.
• Perform trimming, washing, and pre-cleaning steps following SOPs and batch records.

Processing and Treatment

• Prepare solution baths (ethanol, saline, etc.) and perform processing steps per controlled procedures.
• Perform timing, agitation, transfer, and storage steps per validated work instructions.
• Maintain segregation of batches and prevent cross-contamination.
• Assist with downstream manufacturing processes as required.

Documentation

• Complete batch manufacturing records accurately and in real time.
• Record lot numbers, waste, deviations, yields, and environmental details.
• Assist with full traceability throughout the pericardium lifecycle.

Quality

• Operate in controlled areas (cleanrooms or controlled processing rooms) following gowning and behavior rules.
• Perform equipment cleaning, sanitization, and daily checks.
• Identify non-conformances and raise Deviations as needed.
• Follow ISO 13485 and internal QMS requirements.

Training

• Complete GMP training at least annually.
• Complete all required training for assigned duties.
• Maintain and update all required training documentation.

Equipment & Safety

• Operate tools and equipment safely.
• Maintain housekeeping and cleanliness of processing areas.
• Handle chemicals in accordance with WHS and SDS requirements.

Skills, Knowledge, Experience & Qualifications

• Certificate III / IV in Laboratory Techniques, Biological Sciences, Animal Science, or Medical Device Manufacturing, or equivalent industry experience (desirable).
• Knowledge of general laboratory practices; familiarity with GMP, ISO 13485, or other regulated manufacturing environments is desirable.
• Ability to follow SOPs and accurately record information.
• High attention to detail and strong focus on traceability.
• Prior experience working in small, multi-disciplinary teams (desirable).
• Proficiency with Microsoft Office applications.
• Strong communication and interpersonal skills.
• Ability to work in laboratory and cleanroom settings with PPE and gowning requirements.
• Comfort working with animal tissue and chemicals (e.g., ethanol).

WHAT WE OFFER

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Collaborative and dynamic work environment with a culture of innovation and excellence.
• The chance to be part of a growing company that values its teams.