Senior Process

2 weeks ago

Christchurch, New Zealand Eq Consultants Full time

Based in the vibrant city of Christchurch, New Zealand, Canterbury Scientific is a prominent figure in the global medical diagnostic sector. We take pride in being a leading OEM supplier, specialising in high-quality, stable IVD controls for diabetes and hemoglobinopathy assays.
At Canterbury Scientific, our core ethos revolves around customer-centricity. We meticulously focus on every aspect of our products, from design and development to manufacturing. Our goal is to tailor our offerings precisely to our customers' specifications and regulatory requirements under ISO 13485, EU IVDR and US FDA 21 CFR 820, ensuring that the result not only meets but consistently exceeds their expectations and requirements.
As we continue to grow, we are seeking a Senior Process & Development Scientist to join our dynamic team and contribute to the product and process development for existing and new products.
The Role:
As the Senior Process and Development Scientist, you will play a crucial role in the planning, design and development of manufacturing processes for our cutting-edge diagnostic control solutions. You will collaborate closely with our quality and production teams to ensure the highest standards of quality and efficiency. Your work will directly impact the reliability and consistency of products used in critical diagnostic testing worldwide.
Key Responsibilities:
Process Technical Support:
Support the design, development, and optimisation of manufacturing processes for producing high-quality diagnostic control solutions, particularly for HbA1c and other diabetes markers.
Development and amendment of SOPs, WIs and BMRs related to the manufacturing processes.
Ensure all processes comply with international IVD standards, including ISO 13485 and GMP, making sure that all tasks are within company QMS requirements.
Process Development:
Drive innovation in process development, enhancing quality, stability, and manufacturing efficiency.
Work closely with cross-functional teams to integrate new processes into existing manufacturing lines.
New Product & Process Development:
Perform rigorous testing and validation of new processes to meet regulatory and quality control standards.
Identify opportunities for process and product development and implement solutions to enhance productivity, reduce waste, and optimize resource utilization.
Conduct product support studies, assisting in ensuring that products and processes meet manufacturing requirements.
Who We're Looking For:
Post graduate degree in Bioengineering, Biomedical Science, or related discipline.
5+ years of experience in process development or manufacturing, ideally within the IVD or medical diagnostics industry.
A core understanding of protein chemistry and related bioprocessing technologies for their purification and production.
Advanced project management skills.
Strong understanding of regulatory frameworks (ISO 13485, FDA regulations, CE marking) and practical haematology experience.
Proven experience with process scale-up from diagnostic lab to production environments in a GMP or QMS setting.
Sound people management experience.
Ability to collaborate with cross-functional teams and work in a fast-paced, innovative environment.
Exceptional communication and interpersonal abilities with a commitment to your field and a strong professional intelligence.
If you're passionate about process innovation and looking for an opportunity to make a real difference in medical diagnostics, please apply now. For a confidential conversation about the role, please contact EQ Consultants - Steve Kennedy on ******** or Jenny Barr on ********.

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