Qualification and Commissioning Engineer

Work for world renowned biotech company CSL!

Job Title: C&Q Engineer - Qualification/Commissioning Specialist (4 position available)

Position Location: Broadmeadows

Assignment length: Initial 6-month assignment with the potential to extend

Pay rate: up to $63ph + super

Position Purpose:
- The C&Q Engineer is responsible for planning, developing, and executing commissioning and qualification activities to industry and regulatory standards for CSL Behring Australia.
- This role plays a critical part in ensuring compliance with CSL's Code of Responsible Business Practice, Global Quality Policy, CSL Behring (Australia)'s Quality Manual, and current Good Manufacturing Practice.

Main Responsibilities and Accountabilities:

- Perform core activities including Qualification/Commissioning, Commissioning, DMS maintenance, document review, preparation of protocols and reports, supporting other PALM activities, and test equipment maintenance.
- Collaborate with stakeholders to plan and deliver activities efficiently, including Process Engineering, Project Delivery, Execution System, PALM Validation, PALM Stability, Value Streams, R&D, QC staff, and others.
- Prepare, implement, and maintain departmental documentation for activities and regulatory submissions.
- Actively participate in problem-solving and identify opportunities for improvement.
- Assist with HS&E Risk Assessments and implementation of safety improvement initiatives.
- Ensure training is maintained and provide training to new staff as required.

Education: A relevant science or engineering tertiary qualification (or suitable experience).

Must Haves:
- Sound knowledge of cGMP, industry guidance documents, and standards.
- Strong communication, presentation, interpersonal, time management, problem-solving, and negotiation skills.
- Customer-focused with the ability to work with changing priorities and multiple tasks.

Highly Desirable:
- Computer literacy and experience using Microsoft applications.
- Experience in the pharmaceutical manufacturing industry.
- Filling Line and Sterilisation Equipment/Processes

Nicole Consterdine - IPA
***************@ipa.com.au