Senior Validation Specialist

Vertali APAC Pty Ltd; City of Melbourne; On-site; AUD 120,000 - 160,000; Full time

Job summary

CSL Seqirus seeks a Senior Validation Specialist for their Melbourne Airport facility. The role covers qualification planning, execution, and continuous improvement of validation activities across equipment, facilities and processes.

You will partner with Manufacturing, QC, QA and cross-functional teams to ensure compliant, timely validation outcomes. The candidate will bring a strong cGMP background in biological/pharmaceutical manufacturing, with 6+ years of relevant experience and proven

Qualifications

• Bachelor's degree in engineering, technical or science related field is required.
• cGMP background in Biological or Pharmaceutical Industry.
• Good understanding of QMS and Risk Management.
• 6+ years of biological or pharmaceutical manufacturing experience or equivalent roles.
• Knowledge of cGMPs, EU and FDA regulatory guidelines and validation principles.

Responsibilities

• Provide initial qualification, re-evaluation and re-qualification support for qualification of equipment, facilities and processes.
• Define validation scope, schedules and resourcing in collaboration with Validation Manager.
• Own, manage and execute validation deliverables and programmes within the assigned area.
• Document and complete validation activities and build cross-functional relationships.
• Lead validation issue resolution and deviation investigations; drive process improvements.

Skills

Leadership

Time management

Communication

Cross-functional collaboration

Multitasking

Technical writing

Education

Bachelor's degree in engineering/technical/science

Job description

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 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.