The Opportunity
CSL Seqirus is a global leader in influenza prevention and pandemic preparedness.
We are seeking a Senior Validation Specialist to join our team at our state of the art, manufacturing facility at 2 Sky Rd, Melbourne Airport VIC ****.
Description of the Role
The Senior Validation Specialist 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, and utilities) and processes.
You will own and manage validation deliverables across the site cool rooms and cleanrooms.
This position will primarily work across our Flu Cell Culture (FCC) area which include FCC vaccines (FCC facility) at Seqirus.
You will also support work at our Woodend site or PNS facility (Tullamarine), although primarily, you will be working based at and working at Tullamarine.
This is a Permanent full-time position.
Responsibilities
Act as SME supporting Validation Manager to define validation scope, schedules, and resourcing
Own, manage, and execute validation deliverables and programmes within assigned area
Document and complete validation activities as directed
Build robust, candid relationships within Validation and cross‐functional teams
Influence coordinators and managers to align with validation priorities
Collaborate closely with Manufacturing, QC, Sterility Assurance, MS&T;, AS&T;, Warehouse, Engineering, Automation, and QA Lead analysis and resolution of complex validation issues and major deviation investigations
Drive validation assessments for departmental and cross‐functional deviations




Identify and lead validation process improvements and key projects
Support delegation of responsibilities between Validation Specialist and Validation Manager as required
Travel up to 10% as needed
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
Leadership skills supporting team members and leading activities
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
This role requires a strong understanding of the process of commissioning, qualification and validation
It is required that this experience is gained through practical experience within a validation function, with evidence of experience across multiple validation competencies
The level of experience required may typically be found through 6+ years of biological or pharmaceutical manufacturing experience, or through equivalent applicable roles
Validation experience within Pharmaceuticals, and demonstrated knowledge of cGMPs, EU and FDA regulatory guidelines, and validation principles required
Application Period




Applications open on 4 September **** and close on 4 October ****.
About CSL Seqirus
CSL Seqirus is part of CSL.
As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.
With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit / and CSL Plasma at /.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are.
It fuels our innovation day in and day out.
By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit
Equal Opportunity Employer
CSL is an Equal Opportunity Employer.
If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit .
CSL is an Equal Opportunity Employer.
If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here.
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📌 Senior Validation Specialist (Victoria)
🏢 Csl Plasma
📍 Victoria