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 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.
- Positive 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 Perks
- 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 Benefits 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