Validation Associate

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• Validation Associate
• Open to candidates on working holiday visa
• Hourly Rate up to $51.75 + Super an hour

• Request ID: 37250-1
• Start/End Dates: 28/07/2025 - 30/12/2025
• Worker Location: Seqirus AU - Parkville
• Job Title: Quality Control - Quality & Validation Specialist
• Hourly Rate: $51.75 + Super

This role is responsible for performing validation activities associated with changes to existing plant, equipment and processes and revalidation of processes and equipment for the Australia business. The role is also responsible for performing the project validation and routine revalidation activities as determined by the Validation Senior Associates/Validation Managers. The role will be allocated to one of three workstreams which are dedicated to a selection of facilities for priority.

Must haves:

• Validation experience in pharmaceutical industry
• Document and protocol writing, report writing
• Cleaning and equipment validation experience

Nice to haves:

• autoclave validation, process validation and media fill experience highly desired
• computer system validation

Role:

• Performing validation activities for project work
• Temperature mapping
• Media fills
• SOP updates
• Drafting Protocols and reports
• Executing validation activation, equipment validation
• HVAC protocol review, temperature mapping
• (Site operating until early 2026)

Responsibilities:

• Perform the validation activities associated with changes to existing plant, equipment and processes and the project validation activities as determined by the Validation Project Facilitation department to deliver successful validation outcomes for the Seqirus Australia business
• Perform validation activities in accordance with the Quality Management System, Site Validation Master Plan, Business Improvement and Validation procedures to meet the requirements of all codes, regulations and policies
• Prepare, implement and maintain departmental documentation for validation activities and regulatory submissions (i.e. Validation protocols and reports, Executive Summaries and Validation Master Files)
• Build and maintain strong collaborative relationships with key stakeholders
• Participate in internal (e.g. Quality Compliance, Safety and departmental) and external (e.g. TGA, FDA) audits, as requested
• Actively participate in problem solving and identify opportunities for improvement to optimise validation activities
• Ensure all training certification requirements are up-to-date
• Follow the documented procedures to maintain a safe work environment in compliance with company policies, procedures and statutory obligations
• Assist with EHS Risk Assessments and the implementation of safety improvement initiatives
• All employees shall ensure their own and others health, safety and security at work

Essential Skills, Knowledge & Attributes:

• Sound knowledge of cGMP
• Sound knowledge of industry guidance documents and standards, with a good understanding of validation principles
• Good verbal and written communication skills
• Good presentation, interpersonal and time management skills
• Computer literacy and experience using Microsoft applications and familiarity with SAP, eQMS, GLIMS Sound problem solving and negotiation skills
• Strong customer focus.