Job Description
Process Development and Validation Engineer
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Tetratherix is in motion. We're one of Australia's fastest-growing and high profile medical technology companies — recently listed on the ASX — and building a recent generation of biomaterials designed to transform patient care.
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We move fast. We experiment. We hold ourselves to the highest standards of science and manufacturing integrity. And we're now looking for a Process Development & Validation Engineer who wants to build, validate, and scale what's next.
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About the Role
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Reporting to the Production Lead, you'll play a critical role in bridging innovation and manufacturing excellence. You'll drive process scale-up, equipment and process validation, and new product introduction, ensuring that every step we take is both efficient and compliant under ISO *****.
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You'll work closely with cross-functional teams — from R&D; to Quality and Operations — translating breakthrough science into reliable, validated, and scalable production.
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Key Responsibilities
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Assist in manufacturing scale-up, process validation, and equipment qualification.
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Develop and optimise production procedures, SOPs, and batch records.
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Support qualification of new production sites and equipment, liaising with external consultants.
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Contribute to design and validation of new product processes.
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Document test plans, protocols, and results with precision, supporting continuous improvement efforts.
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Ideal Candidate
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Bachelor's or Master's in
Chemical/Biomedical
Engineering or related fields.
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2+ years' experience in the Medical Device industry, familiar with ISO *****.
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Proven expertise in process, equipment, and product validation.
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Strong problem-solving, documentation, and communication skills.
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Proficient in Microsoft Office.
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Why Tetratherix?
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Because here, you build what matters. You'll join a team that's curious, collaborative, and relentless in its pursuit of better outcomes for patients and clinicians. You'll see your work move from the lab to real-world impact — and you'll do it alongside people who are rewriting what's possible in medical technology.
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Ready to make a difference?
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Apply now by sending your resume and cover letter to
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📌 Process Development And Validation Engineer (New South Wales)
🏢 Tetratherix
📍 New South Wales