Validation Engineer

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 Senior Validation Engineer you will manage process and cleaning validation activities for projects and changes to processes. In this important role you will ensure that processes are measurable, repeatable, compliant and meet both quality and regulatory requirements.

The Role

Reporting to the Validation Lead and working on site at Broadmeadows, you will:

• Work across the organisation ensure validation activities for projects and associated with changes to existing processes/materials, new processes/materials and projects are planned and performed efficiently;

• 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;

• Prepare, review, implement and maintain validation documentation including procedures, templates, project plans, risk assessments and validation master plan for site processes;

• Participate in investigations for validation deviations (root cause analyses, impact analyses, CAPA definitions);

• Participate in change control panels and assess the impact of change controls on validation status;

• Perform Quality Assurance GMP reviews or approvals of qualification related documents

Your skills and experience

To be considered for this role you must have:

• A degree in science or engineering;

• 5 plus years’ experience in the pharmaceutical manufacturing industry in a cGMP environment;

• 5 plus years’ experience in Process or Cleaning Validation;

• Current knowledge of industry guidance documents and standards focusing on validation principles and applications relevant to process and cleaning validation;

• 3 plus years’ experience in a role requiring conceptual and analytical thinking and judgement to reconcile ambiguities;

  • Experience in a role completing multiple projects with competing deadlines;
  • Experience in a role requiring collaboration and persuasion to influence outcomes.

How to Apply:

Please apply with your resume and cover letter, which must address the selection criteria above, and include the reference number R-199221 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.

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.

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