Quality By Design Coordinator

3 weeks ago


Melbourne, Australia Design & Build Recruitment Full time

**The Opportunity**
We are seeking a Process Engineer to join our global pharmaceutical client. The role is to support day-to-day business and project execution within the Process Engineering team. The position focuses on delivery and maintenance of technical risk assessments and reports to support manufacturing process knowledge management.

**The Role**
Reporting to the Global Lead for Quality by Design LCM, key responsibilities include the following:

- Coordination with SMEs for compilation of technical reports and risk assessment for manufacturing processes in accordance with global SOPs, templates, and best practices.
- Documentation management and data maintenance to support knowledge management activities. Works with key SMEs for routine integration of historical, real time process monitoring, and deviation data outcomes into QbD knowledge management packages to inform efficient and accurate decision making.
- Communicate and collaborate with colleagues to provide support for technical reviews, projects or process
- Assisting with documentation
- Generating technical reports and risk assessments for manufacturing processes
- Coordinate meetings with SME to gather information
- Technical report writing, word and excel

**Skills & Experience**
- Bachelor’s degree required in Engineering or Science discipline
- 2-5 years minimum working in Process Engineering in Pharmaceutical/Biotech Operations, Chemical Manufacturing or similar industry. Master’s degree with 1-2 years of experience
- Experience in pharmaceutical/biotech operations preferred
- Experience with regulated environments (i.e. cGMP, OSHA, EPA) preferred

Additional Info:

- Team size: 3-4
- Flexibility?: Some work from home available, but need to be available at Broadmeadows for face to face meeting when needed
- Hours: Mon to Fri standard hours, though there are some occasional global calls with EU and US teams
- Potential to extend?: possible
- Reports to: Lifecycle Management Quality By Design Global Lead

Design & Build specializes in recruitment for the Construction, Manufacturing, Engineering & Property industries on a national basis. Design & Build prides itself on only hiring recruitment specialists, finding the right people for the right jobs and doing the right thing by both job seekers and employers alike.

For any questions relating to this role please contact

Thanks for your consideration.


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