CSL Seqirus is a global leader in influenza prevention and pandemic preparedness. We are seeking an Senior Validation Specialist to provide initial qualification support for equipment at our state-of-the-art manufacturing facility in Tullamarine.
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 products of national significance area which include Flu Cell Culture vaccines (FCC facility) at Seqirus. You will also support work at our Woodend site, although primarily, you will be working based at and working at Tullamarine.
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.
