Validation Associate
- Provide qualification and requalification support for equipment and processes.
- Document validation tasks and own deliverables as directed by the Validation manager.
- Develop strong working relationships with stakeholders across the site.
The Opportunity
CSL Seqirus is a global leader in influenza prevention and pandemic preparedness. We are seeking a part-time (3 days per week) Validation Associate to provide initial qualification/requalification support for equipment, process, cleaning, facility, utilities, transport, computer systems at our state-of-the-art manufacturing facility in Tullamarine.
The Validation Associate will provide initial qualification (including determining requirements for qualification), re-evaluation and re-qualification support for the design, start-up, commissioning and qualification of equipment (including associated computer systems, facilities, process validation, cleaning validation, equipment qualification, transport and utilities) and processes.
This position will primarily work across our flu cell culture area at Seqirus. You could also support work in the Products of National Significance (PNS) facility in Tullamarine and at our Woodend site, although primarily, you will be working based at and working at Tullamarine.
Responsibilities:
Document and complete validation tasks in support of projects and routine requalification.
Own validation deliverables as directed by the Validation manager and execute as required.
Develop strong working relationships with stake holders across the site.
Analyse information and regulatory standards to problem solve using logic and judgement to identify appropriate complaint solutions.
Complete deviations as required,
Skills and experience:
cGMP background in Biological or Pharmaceutical Industry.
Experience in Biological or Pharmaceutical Industry.
Bachelor’s degree is required in engineering, technical or science related field.
Good understanding of QMS and Risk Management.
Time management skills for the execution and planning of work.
Good communication skills both written and verbal, with excellent technical writing skills.
Ability to multitask and work cross functionally and to work within a team environment and independently.
How to Apply
If you are interested join a team that’s making real change in the lives of patients, please submit your application including your resume.
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