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Process Development Engineer

2 weeks ago

Auckland City, New Zealand Aroa Biosurgery Full time

At AROA, our people come to work every day with passion and ideas that fuel our business and go home knowing they have made a real difference in the lives of others.

AROA, which is Maori for ‘understanding ’, is proudly New Zealand born and based. We develop, manufacture, and export innovative wound care products, improving the lives of millions around the world by unlocking extraordinary outcomes for our patients. Our mission is to be the global leader in regenerative healing, making our products and services accessible to everybody.

**About the role**:
We are se e ki ng a Process Development Engineer to ens ure the quali ty and reliabil ity of our medica l device products from pilot processes to commercial scale-up and transfer. This position demands expertise in validation, chemical process development, and the ability to collaborate effectively with internal stakeholders including engineering, manufacturing, quality and regulatory teams. Other key responsibilities include:

- Plan and execute process development studies
- Perform validation activities such as, but not limited to, IQ/OQ/PQ
- Collaborate with internal stakeholders, Engineering, and Quality teams to ensure smooth design transfer of new products into manufacturing
- Support Design Controls in process risk assessment activities (e.g. pFMEA) where technical input is required
- Identify opportunities for process optimisation and efficiency improvements

Perform root cause analysis to support manufacturing activities**What**you’ll**bring**:
To be successful in this role, you’ll have a bachelor’s degree in engineering, along with 3 + years’ experience in similar role s. We are open to consider ing experience in the medical, pharmaceutical or other highly regulated sectors. You’ll have hands-on experience with chemical process development and validation and be comfortable using statistical analysis tools such as Minitab.

Experience with equipment and cleaning validations, sterilization processes, project management, a nd familiarity working in both laboratory and workshop environments are desirable but not essential.

**What’s**in it for you**

We have an onsite gym, free exercise classes and yoga, and our staff enjoys taking part in our
cultural celebrations run by the Wellness Team such as Lunar New Year, Diwali and Mataraki. You’ll also get to take your birthday off
Based in Airport Oaks with easy access to the motorway, there is plenty of free parking available around our offices.

To be considered for this opportunity you must have existing NZ working rights.