Job Description
The Opportunity
Join the CSL Behring Validation team on a full-time permanent basis. 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.
As the Validation Engineer you will complete validation activities for projects and associated with changes to existing processes/materials, new processes/materials and projects following the Site Validation Master Plan and validation procedures.
The Role
Reporting to the Validation Lead and working on site at Broadmeadows, you will:
- Prepare and maintain departmental documentation for validation activities and regulatory submissions (e.g. validation protocols and reports, executive summaries and validation master files);
- Contribute to the creation of validation concepts and help develop Project Validation Plans;
- Evaluate and review validation data and identify opportunities for improvement to optimise validation activities;
- Help provide technical specialist advice on validation issues to project and department team members;
- Help complete investigations for validation deviations (root cause analyses, impact analyses, CAPA definitions);
- Help solve problems and identify opportunities to improve validation activities;
- Support internal audits and external regulatory inspections.
Your skills and experience
To be considered for this role you have:
- A degree in science or engineering;
- 3 plus years’ experience in the pharmaceutical manufacturing industry in a cGMP environment;
- Knowledge of industry guidance documents and standards focusing on validation principles and applications relevant to process and cleaning validation;
- Experience using statistical analysis software;
- Experience preparing written technical documents and presenting complex information;
- Experience in a role with changing priorities and multiple tasks.
How to Apply:
Please apply with your resume and covering letter, which must address the selection criteria above, and include the reference number R-199222 by March 31, 2023.
About Us
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, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
Do work that matters at CSL Behring!