Job Description

- 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.,
- 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

About the Employer

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., 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.

About the Candidate

- 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 robust 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.

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