Process Development and Validation Engineer

1 day ago

Sydney, New South Wales, Australia Tetratherix Full time $90,000 - $120,000 per year

Process Development & Validation Engineer

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 new generation of biomaterials designed to transform patient care.

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.

About the Role

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 13485
.

You'll work closely with cross-functional teams — from R&D to Quality and Operations — translating breakthrough science into reliable, validated, and scalable production.

Key Responsibilities

  • Assist in
    manufacturing scale-up, process validation, and equipment qualification.
  • Develop and optimise
    production procedures, SOPs, and batch records
    .
  • Support qualification of n
    ew production sites and equipment
    , liaising with external consultants.
  • Contribute to
    design and validation of new product processes
    .
  • Document test plans, protocols, and results with precision, supporting continuous improvement efforts.

Ideal Candidate

  • Bachelor's or Master's in
    Chemical/Biomedical Engineering
    or related fields.
  • 2+ years' experience in the Medical Device industry,
    familiar with ISO 13485
    .
  • Proven expertise in
    process, equipment, and product validation
    .
  • Strong problem-solving, documentation, and communication skills.
  • Proficient in Microsoft Office.

Why Tetratherix?

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.

Ready to make a difference?

Apply now by sending your
resume
and
cover letter
to

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