Job Description
Job Description
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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.,
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Act as SME supporting Validation Manager to define validation scope, schedules, and resourcing
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Own, manage, and execute validation deliverables and programmes within assigned area
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Document and complete validation activities as directed
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Build solid, candid relationships within Validation and cross-functional teams
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Influence coordinators and managers to align with validation priorities
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Collaborate closely with Manufacturing, QC, Sterility Assurance, MS&T;, AS&T;, Warehouse, Engineering, Automation, and QA
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Lead analysis and resolution of complex validation issues and major deviation investigations
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Drive validation assessments for departmental and cross-functional deviations
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Identify and lead validation process improvements and key projects
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Support delegation of responsibilities between Validation Specialist and Validation Manager as required
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Travel up to 10% as needed
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About the Employer
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CSL Seqirus is a global leader in influenza prevention and pandemic preparedness.
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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 ****., 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.
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About the Candidate
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cGMP background in Biological or Pharmaceutical Industry.
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Experience in Biological or Pharmaceutical Industry
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Bachelor's degree is required in engineering, technical or science related field.
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Good understanding of QMS and Risk Management
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Leadership skills supporting team members and leading activities
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Time management skills for the execution and planning of work.
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Good communication skills both written and verbal, with excellent technical writing skills
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Ability to multitask and work cross functionally
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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.

📌 Senior Validation Specialist (Victoria)
🏢 Vertali APAC
📍 Victoria