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 is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines and therapies, 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 ****., 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 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.
Work Environment
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short-Term Disability
Long-Term Disability
FSA
HSA
Mental Health Benefits
Parental Benefits
Adoption Leave
Birth Parent or Maternity Leave
Non-Birth Parent or Paternity Leave
Fertility Benefits
Adoption Assistance Program
Family Support Resources
Work Flexibility
Office Life and Perks
Commuter Perks Program
Vacation and Time Off
Paid Vacation
Paid Holidays
Personal/Sick Days
Leave of Absence
Volunteer Time Off
Financial and Retirement
401(K) With Company Matching
Stock Purchase Program
Financial Counseling
Professional Development
Tuition Reimbursement
Diversity and Inclusion
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📌 Validation Specialist (Melbourne)
🏢 Vertali APAC
📍 Melbourne