CPS Support Operations Technician

The Clinical Protein Suite (CPS) Support Operations Technician role is a fundamental support function within our clients state of the art research and development facility in Melbourne CBD.   

The CPS is a GMP pilot facility which produces early phase material for clinical studies. Activities within the CPS require operational support; this may include equipment collection washing sterilisation and consumable/equipment kitting. Additionally to ensure the facility is operational other peripheral support activities include gown removal/restocking consumables stocking periodic waste management etc. 

Operations within the CPS to support GMP early phase manufacturing activity within the facility includes - 

Support Areas for the CPS

• Bulk Wing Equipment Wash.
• Bulk Wing Equipment Preparation.
• Bulk Wing Equipment Store.
• Filling Wing Equipment Wash/Prep.
• Filling Wing Equipment Store.
• Filling Wing Material Store.
• Filing wing Solution Preparation (as required).

Routine tasks include

• Equipment washing and drying.
• Equipment sterilisation.
• Decartoning of consumables and affixing of identifying labels as appropriate.
• Movement of consumables into the facility to internal storage locations.
• Subsequent kitting of consumables and equipment preparation for production operations.
• Restocking of facility gowns etc.
• Potential ad hoc requirement for waste management.
• Collection & preparation of equipment for cleaning and/or sterilisation
• Ensuring compliance with the client sites OHS / QA Systems and regulatory requirements.

Support Solution Preparation Team with the following: 

• Weighing & dispensing of raw materials
• Equipment preparation e.g. set up of single use preparation vessels / mixers and balance calibration
• Dissolution of dispensed powders pH/conductivity/volume adjustment of resultant solution to specification
• Sampling and offline testing of prepared solutions
• Final filtration of the solution into storage bag(s)
• Integrity testing of used filters
• Captuirng & recording steps perfomed via electronic record systems

Data and Reports

• All activities will be captured via electronic record systems that details the equipment and consumables (if applicable) used and adherence to specified method.
• Clean equipment must be labelled with date of clean or if sterile equipment then date of sterilisation and log number.

People performing the above activities will report to the Facility Support Lead.

Qualifications :

As an important role within Eurofins PSS the following selection criteria are essential for success:

• Laboratory Skills TAFE certificate / Diploma in an appropriate scientific field preferred.
• Previous GMP experience of 2 or more years (preferred).
• Very good understanding of requirements for working in a GMP environment is essential.
• Willing to operate in a flexible manner and be able to switch priorities at short notice.
• Good team player organised accurate have strong documentation skills.
• Good communication skills both internally and externally. Capable of collaborating with cross-functional teams.
• Demonstrate problem solving in delivering process and analytical understanding.

PREFERRED SKILLS AND SUCCESS PROFILE:

• Builds Customer Allegiance
• Focus on Growth
• Job Knowledge
• Teamwork / Collaboration 
• Interpersonal Skills
• Dependability
• Safety First Mindset
• Personal Development
• Problem Solving / Decision Making

Additional Information :

• Willing to operate in a flexible manner and be able to switch priorities at short notice.
• Good team player organised accurate have strong documentation skills.
• Demonstrate problem solving in delivering process and analytical understanding.
• Good understanding of requirements for working in a GMP environment.
• Occasional weekend and public holiday work will be required.
• Ability to quickly learn new processes.

Please note: Current Eurofins employees should first speak with their Business Unit Manager before submitting an application for this position.

We will be reviewing applications as they are received so if you believe you are ready for this exciting challenging and rewarding position please apply as soon as possible by submitting your resume and a cover letter that outlines your interest and suitability for the position.

This opportunity is only open to candidates who are eligible to work in Australia/New Zealand and already have work rights or an appropriate working visa.

Remote Work :

No

Employment Type :

Full-time