Senior Validation Specialist

CSL Limited; City of Melbourne; On-site; AUD 110,000 - 160,000; Full time

Job summary

CSL Seqirus in Melbourne is seeking a Senior Validation Specialist to lead qualification, re-qualification and validation activities for equipment, facilities and processes within the FCC area and related sites. You will own validation deliverables across the site, working with Manufacturing, QC, QA and cross-functional teams.

The role requires a strong cGMP background, a bachelor’s degree in engineering/science and 6+ years in biopharma manufacturing, with willingness to travel up to 10% and to

Qualifications

• Bachelor’s degree is required in engineering, technical or science related field.
• 6+ years in biopharma manufacturing.

Responsibilities

• Define validation scope, schedules, and resourcing.
• Own and execute validation deliverables and programmes.
• Document validation activities as directed.
• Collaborate with cross-functional teams.
• Lead deviation investigations and validation trends.
• Travel up to 10% as needed.

Skills

cGMP background

Biopharma experience

Leadership

Time management

Communication

Cross-functional collaboration

Education

Bachelor’s degree in engineering/science

Job description

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 3045.

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 3045.

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 strong, 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 2026 and close on 4 October 2026.

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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

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 https://www.csl.com/careers/inclusion-and-belonging

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 https://www.csl.com/accessibility-statement.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus