Validation Associate

3 weeks ago

Parkville, Victoria, Australia CSL Full time

The Opportunity

CSL Seqirus is a global leader in influenza protection, with a presence in the Asia Pacific region. We manufacture and distribute a range of uniquely Australian products and market in-licensed vaccines and pharmaceuticals in Australia and New Zealand.

We are seeking a Validation Associate to join our Quality Assurance (QA) Validation team in Parkville on a full-time fixed-term basis until 30 June 2026. Reporting to the Validation Manager, you will provide validation support for process, cleaning, and equipment and any projects. You will also support revalidation activities across the Seqirus business.

The Role

You will be based on-site at Parkville (Australia) but with some time required at Tullamarine. Your responsibilities will include:

  • Performing validation activities associated with changes to existing plant, equipment, and processes and project validation activities as determined by the Validation Project Facilitation department to deliver successful validation outcomes for the Seqirus Australia business.
  • Performing validation activities following the Quality Management System, Site Validation Master Plan, Business Improvement, and Validation procedures to meet the requirements of all codes, regulations, and policies.
  • Preparing, implementing, and maintaining departmental documentation for validation activities and regulatory submissions (e.g., Validation protocols and reports, Executive Summaries, and Validation Master Files).
  • Building and maintaining collaborative relationships with important partners.
  • Participating in internal (e.g., Quality Compliance, Safety, and departmental) and external (e.g., TGA, FDA) audits.
  • Participating in problem-solving and identifying opportunities for improvement to optimize validation activities.
  • Ensuring all training certification requirements are up-to-date.
  • FOLLOWING THE DOCUMENTED PROCEDURES TO MAINTAIN A SAFE WORK ENVIRONMENT IN COMPLIANCE WITH CSL POLICIES, PROCEDURES, AND STATUTORY OBLIGATIONS.
  • Assisting with EHS Risk Assessments and the implementation of safety improvement plans.
  • All employees shall ensure their own and others' health, safety, and security at work.

Your Skills and Experience

To be considered for this role, you will have:

  • A bachelor's degree in an Engineering or Science-related field.
  • 3+ years' experience in the Pharmaceutical Industry in a validation, quality assurance, or engineering-related role, applying validation protocols to systems, processes, cleaning, and equipment.
  • Knowledge of the manufacturing of sterile injectables.
  • Knowledge of GMP, QMS, and Risk Management.
  • Experience in a role requiring cross-site collaboration and multi-tasking.
  • Excellent communication skills, including experience in technical writing.
  • Experience with machinery and equipment.

How to Apply

Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-234141 by 4 July 2024.

#LI-ONSITE

Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.

  • Validation Associate

    3 weeks ago

    Parkville, Victoria, Australia CSL Full time

    The OpportunityCSL Seqirus is a global leader in influenza protection, with a presence in the Asia Pacific region. We are seeking a skilled Validation Associate to join our Quality Assurance (QA) team in Parkville, Australia.The RoleAs a Validation Associate, you will be responsible for providing validation support for process, cleaning, and equipment, as...

  • Validation Specialist

    1 week ago

    Parkville, Victoria, Australia CSL Full time

    The OpportunityCSL Seqirus is a global leader in influenza protection, with a presence in the Asia Pacific region. We are seeking a skilled Validation Associate to join our Quality Assurance (QA) Validation team in Parkville, Australia.The RoleAs a Validation Associate, you will be responsible for providing validation support for process, cleaning, and...

  • Validation Specialist

    2 months ago

    Parkville, Victoria, Australia CSL Full time

    The OpportunityCSL Seqirus, a global leader in influenza protection, is seeking a skilled Validation Associate to join our Quality Assurance (QA) Validation team in Parkville. As a key member of our team, you will provide validation support for process, cleaning, and equipment, as well as revalidation activities across the Seqirus business.The RoleBased...

  • Clinical Teaching Associate

    2 weeks ago

    Parkville, Victoria, Australia University of Melbourne Full time

    Clinical Teaching AssociateAbout the RoleClinical Teaching Associates (CTAs) from the community are integral to the Department of Medical Education's Sensitive Physical Examinations Program. CTAs receive training to simulate patients for gynaecological and breast examinations. They assist in teaching medical students these essential examination skills,...

  • Associate Director Business Development

    4 weeks ago

    Parkville, Victoria, Australia 2012 CSL Behring L.L.C. Full time

    Job SummaryWe are seeking an experienced Associate Director Business Development to join our team at CSL Behring. This role will be responsible for leading business development and licensing activities globally, aligned with our company strategy. The successful candidate will have a strong background in business development and licensing, with a proven track...

  • Senior Research Scientist

    1 week ago

    Parkville, Victoria, Australia University of Melbourne Full time

    About the RoleThe University of Melbourne seeks a highly skilled Research Fellow to join the Lewin Laboratory within the Department of Infectious Diseases at the Peter Doherty Institute for Infection and Immunity.This role involves developing innovative antiviral therapeutics using gene editing tools and lipid nanoparticles, particularly focusing on...

  • Data Analyst

    1 month ago

    Parkville, Victoria, Australia theroyalch Full time

    About the RoleThis is a Permanent Full Time position at 1.0 FTE - 80 hours per fortnight within the Decision Support Unit. You will be responsible for report and extract development along with maintenance and analysis tasks primarily using Epic's Clarity database and Decision Support's enterprise data warehouse. You will work with key RCH stakeholders to...

  • Data Analyst

    3 weeks ago

    Parkville, Victoria, Australia theroyalch Full time

    About the Role:This is a Permanent Full Time position at 1.0 FTE - 80 hours per fortnight within the Decision Support Unit. You will be responsible for report and extract development along with maintenance and analysis tasks primarily using Epic's Clarity database and Decision Support's enterprise data warehouse. You will work with key RCH stakeholders to...

  • Senior Quality Expert

    4 days ago

    Parkville, Victoria, Australia 3065 CSL Innovation Full time

    The Role:CSL is seeking an R&D Senior Quality Advisor to ensure compliance with GMP/GSP or other GxP requirements. The successful candidate will investigate deviations, implement corrective and preventative actions, and facilitate change controls.Key Responsibilities:Provide quality compliance leadership and oversight for Product Development Expert Team...

  • Payroll Officer

    1 month ago

    Parkville, Victoria, Australia theroyalch Full time

    About the RoleThis is a Fixed term Full Time position within the Payroll department at The Royal Children's Hospital (RCH). The Payroll Officer is responsible for providing quality advice, service and support to RCH staff and external stakeholders in relation to payroll queries and ensuring payroll processes are effective and efficient and meet RCH...

  • Payroll Officer

    3 weeks ago

    Parkville, Victoria, Australia theroyalch Full time

    About the Role:This is a Fixed term Full Time position within the Payroll department at The Royal Children's Hospital. The Payroll Officer is responsible for providing quality advice, service and support to RCH staff and external stakeholders in relation to payroll queries and ensuring payroll processes are effective and efficient and meet RCH governance...

  • Payroll Officer

    3 weeks ago

    Parkville, Victoria, Australia theroyalch Full time

    About the Role:This is a Fixed term Full Time position within the Payroll department. The Payroll Officer is responsible for providing quality advice, service and support to RCH staff and external stakeholders in relation to payroll queries and ensure payroll processes are effective and efficient and meet RCH governance requirements. You will work closely...

  • Payroll Officer

    2 weeks ago

    Parkville, Victoria, Australia theroyalch Full time

    About the Role:This is a Fixed term Full Time position within the Payroll department at theroyalch. The Payroll Officer is responsible for providing quality advice, service and support to theroyalch staff and external stakeholders in relation to payroll queries and ensure payroll processes are effective and efficient and meet theroyalch governance...

  • Anaesthetic Technologist Role

    6 days ago

    Parkville, Victoria, Australia theroyalch Full time

    About the Role:This is a Casual position as an Anaesthetic Technician. The position provides skilled assistance to medical staff for the safe administration of anaesthesia or sedation as specified in document PS08 2012 (ANZCA) – (recommendations on the Assistant for the Anaesthetist). The successful candidate will ensure all equipment pertaining to the...

  • Global Business Development Director

    4 days ago

    Parkville, Victoria, Australia 2012 CSL Behring L.L.C. Full time

    Job SummaryThe Associate Director Business Development position at CSL Behring is a key role in driving business growth and strategic partnerships. As a senior member of the Business Development and Licensing team, you will be responsible for leading search and evaluation activities, co-ordinating cross-functional due diligence, supporting financial...

  • Facility Operations Manager

    3 weeks ago

    Parkville, Victoria, Australia CSL Full time

    The OpportunityCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza.We are currently recruiting for a Facility Operations Manager to join our Building Operations & Services team at our Melbourne office.Reporting...

  • Senior Quality Advisor

    4 weeks ago

    Parkville, Victoria, Australia CSL Full time

    The Opportunity:We are seeking a highly skilled and experienced Senior Quality Advisor to join our R&D team at CSL. As a key member of our quality assurance team, you will play a critical role in ensuring compliance with GMP/GSP and other GxP requirements.As the Senior Quality Advisor, you will be responsible for investigating deviations and out of...

  • Senior Quality Advisor

    3 weeks ago

    Parkville, Victoria, Australia 3065 CSL Innovation Full time

    The Opportunity:We are seeking a highly skilled and experienced R&D Senior Quality Advisor to join our team at CSL Innovation. As a key member of our Quality Assurance team, you will play a critical role in ensuring compliance to GMP/GSP or other GxP requirements. Your expertise will be instrumental in investigating deviations and out of specifications,...

  • Strategic Business Development Leader

    3 weeks ago

    Parkville, Victoria, Australia 2012 CSL Behring L.L.C. Full time

    Job SummaryWe are seeking a highly skilled and experienced Associate Director Business Development to join our team at 2012 CSL Behring L.L.C. This role will be responsible for leading business development and licensing activities globally, aligned with our company's strategy to optimize our portfolio.Key ResponsibilitiesLead search and evaluation activities...

  • Strategic Business Development Lead

    2 weeks ago

    Parkville, Victoria, Australia 2012 CSL Behring L.L.C. Full time

    Job SummaryCSL Behring is seeking a highly skilled and experienced Associate Director Business Development to lead our global business development and licensing activities. This role will be responsible for identifying and evaluating strategic business opportunities, developing partnership strategies, and negotiating licensing agreements.Key...