The OpportunityCSL 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 ****.Description of the RoleThe 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 Flu Cell Culture (FCC) area which include FCC vaccines (FCC facility) at Seqirus.
You will also support work at our Woodend site or PNS facility (Tullamarine), although primarily, you will be working based at and working at Tullamarine.This is a Permanent full-time position.ResponsibilitiesAct as SME supporting Validation Manager to define validation scope, schedules, and resourcingOwn, manage, and execute validation deliverables and programmes within assigned areaDocument and complete validation activities as directedBuild strong, candid relationships within Validation and cross‐functional teamsInfluence coordinators and managers to align with validation prioritiesCollaborate closely with Manufacturing, QC, Sterility Assurance, MS&T;, AS&T;, Warehouse, Engineering, Automation,



and QALead analysis and resolution of complex validation issues and major deviation investigationsDrive validation assessments for departmental and cross‐functional deviationsIdentify and lead validation process improvements and key projectsSupport delegation of responsibilities between Validation Specialist and Validation Manager as requiredTravel up to 10% as neededThis 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.Skills and ExperiencecGMP background in Biological or Pharmaceutical Industry.Experience in Biological or Pharmaceutical IndustryBachelor's degree is required in engineering, technical or science related field.Good understanding of QMS and Risk ManagementLeadership skills supporting team members and leading activitiesTime management skills for the execution and planning of work.Good communication skills both written and verbal,



with excellent technical writing skillsAbility to multitask and work cross functionallyApplication Period: Applications open on 4 September **** and close on 4 October ****.About CSL SeqirusCSL Seqirus is part ofCSL.
As one of the largest influenza vaccine providers in the world, CSL Seqirusis 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.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .
Our BenefitsFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL .
You Belong at CSLAt CSL, Inclusion and Belonging is at the core of our mission and who we are.
It fuels our innovation day in and day out.
By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.To learn more about inclusion and belonging visit careers/inclusion-and-belongingEqual Chance EmployerCSL is an Equal Opportunity Employer.
If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit accessibility-statement .
Watch our 'On the Front Line' video to learn more about CSL Seqirus
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📌 Senior Validation Specialist (Victoria)
🏢 Biopharma Careers
📍 Victoria