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Senior Validation Engineer

Employer
CSL - Australia
Location
Broadmeadows, AU
Salary
Competitive
Start date
1 Dec 2023
Closing date
16 Dec 2023

View more

Discipline
Manufacturing, Validation
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

The Opportunity

CSL Behring Broadmeadows manufactures a comprehensive portfolio of 15 plasma products for Australia from plasma collected by the Lifeblood Australia. Part of the CSL family, when you join the over 1200 employees at Broadmeadows, you join an integrated global network of research and manufacturing facilities delivering on our 100-year-old promise to save lives using the latest technology.

Join the CSL Behring Process Engineering team on a full-time ongoing basis. As the Senior Validation Engineer, you will manage and perform validation activities for processes and cleaning associated with modifications and changes to processes and projects for the CSL Behring Australia business. Specifically, you will ensure processes are measurable, repeatable and compliant with the Quality Management System, Site Validation Master plan, CSL policies and regulatory requirements.

The Role

Reporting to the Validation Lead and based on-site at Broadmeadows, you will also:
  • Build and maintain relationships across the site to allow validation activities to be planned and performed efficiently
  • Provide technical specialist advice regarding validation to project and department team members
  • Contribute to the creation of validation concepts and the development of Project Validation Plans
  • Help investigate validation related deviations, assess Corrective and Preventative Actions (CAPAs) and participate in change control panels
  • Help prepare, review, implement and maintain validation documentation including procedures, templates, project plans, risk assessments and validation master plan for site processes
  • Perform Quality Assurance GMP review and approval of qualification related documents
  • Promote the education and implementation of the relevant regulatory requirements
  • Support internal audits and external regulatory inspections


Your skills and experience

To be considered for this role, you have:
  • A Bachelor's degree in science or engineering
  • 5+ years' experience in in the pharmaceutical manufacturing industry with experience in Process and/or Cleaning Validation
  • Knowledge of cGMP including current knowledge of industry guidance documents and standards focusing on validation principles and applications
  • Experience working across departments to negotiate and influence outcomes
  • Experience requiring the review of documents and the presentation of complex information verbally and in writing
  • Experience in a role that requires minimal guidance to analyse situations, reconcile ambiguities to make sound risk-based decisions.


How to Apply:

Please apply with your resume and covering letter, which must address the selection criteria above, and include the reference number R-220332 by 15 December 2023

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!

Company

Find out more about working for our company

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Brief Company Description; 

Driven by Our Promise

Delivering on promises is what we do at CSL.

Over a century ago in Melbourne, Australia, we made a promise to save lives and protect the health of people who were stricken with a range of serious and chronic medical conditions. Today, as a leading global biotech company, that same promise has never been stronger. We develop and deliver innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions live full lives. We are driven by our deep passion to serve hundreds of thousands of patients and other stakeholders around the world.

Company info
Website
Mini-site
CSL - Australia
Telephone
+61 3 9389 1911
Location
45 Poplar Road
Parkville
VIC
3052
Australia

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