Validator Coordinator

2 weeks ago

Melbourne, Victoria, Australia beBeeValidation Full time $130,000 - $170,000
Process Validation Lead

The opportunity to join a comprehensive portfolio of plasma products is now available. This full-time permanent role offers the chance to contribute to the manufacture of 15 plasma products for Australia from plasma collected by Lifeblood. As part of the CSL family, you will join an integrated global network of research and manufacturing facilities that deliver on their promise to save lives using the latest technology.

As the Process Validation Lead, you will be responsible for managing process and cleaning validation activities across the CS Behring Australia Business following the Site Validation Master Plan and validation procedures. You will provide guidance to site staff for process and cleaning validation and work across the site to ensure that validation activities are completed efficiently.

The Role:

  • Manage continued process verification activities for CSL Behring Australia.
  • Manage extractable and leachable activities for CSL Behring Australia.
  • Ensure equipment and process control have been installed adequately to allow process and cleaning validation activities to be undertaken.
  • Manage development and maintenance of process and cleaning validation master plans for CSL Behring Australia.
  • Manage departmental documentation for process and cleaning validation activities and prepare validation concepts.
  • Conduct or participate in regulatory audits, investigations for validation deviations, change control panels, and perform assessment of change controls for impact on validation status.
  • Lead a small team and provide support to team to upskill and focused on continuous improvements.

Required Skills and Qualifications:

  • A degree in science or engineering.
  • 5+ years' experience in pharmaceutical manufacturing industry in a cGMP environment with experience in Process and Cleaning Validation.
  • Knowledge of cGMP including industry guidance documents and standards relating to validation.
  • Experience leading a technical team in a regulated environment.
  • Experience in pharmaceutical industry regulatory requirements including TGA & FDA audits.
  • Experience preparing written technical documents and presenting complex information.

Benefits:

We encourage you to make your well-being a priority. It's important and so are you. We offer competitive compensation packages, comprehensive benefits, and opportunities for professional growth and development.

About Us:

We are a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

  • Validation Specialist

    2 weeks ago

    Melbourne, Victoria, Australia Icon Group Full time

    **Pharmaceutical Compounding****Melbourne****Full Time****Slade Health****Validation Specialist - Slade Health**- Wonderful Opportunity to Develop Your Career in a Far-Reaching Organisation- Fantastic Position in a Collaborative Team- Full-Time (Mon-Fri 76-hour f/n)- Permanent Position - Mt Kuring-gai (Sydney) or Mt Waverley (Melbourne) Location- On-site...

  • Senior Validation Specialist

    2 weeks ago

    Melbourne, Victoria, Australia beBeeValidation Full time $90,000 - $125,000

    Job OverviewWe are seeking a Validation Professional to provide support for projects and maintain schedules for initiatives involving validation.Key Responsibilities:Plan, coordinate and execute validation activities according to quality management systems and site validation master plans.Perform validation tasks for project work.Deliver CSV computer systems...

  • Validation Specialist

    2 weeks ago

    Melbourne, Victoria, Australia beBeeQuality Full time $160,000 - $200,000

    Key ResponsibilitiesThe Validation Lead is responsible for overseeing qualification processes, identifying key risks and presenting issues, recommendations and updates to the relevant governance forums or processes.Scope of accountability includes liaison with contractors, suppliers, internal customers, and management/overview (as agreed) of the...

  • Validation Specialist

    1 week ago

    Melbourne, Victoria, Australia beBeeValidation Full time $180,000 - $200,000

    Senior Commissioning, Qualification, and Validation Engineer OpportunityThe Senior Commissioning, Qualification, and Validation (CQV) Engineer is responsible for ensuring that systems, facilities, and equipment meet design requirements.Act as a lead and simplify CQV functions, reports, and processes to enhance efficiency.Support the implementation of safety...

  • Senior Validation Specialist

    2 weeks ago

    Melbourne, Victoria, Australia beBeeEngineering Full time $90,000 - $120,000

    Job Title: Validation AssociateAbout the OpportunityThis is an excellent chance to collaborate with a leading pharmaceutical business on a six-month contract basis located in the inner suburbs of Melbourne.Key Responsibilities:Develop and execute validation strategies for processes, equipment, and cleaning activities as required for assigned...

  • Senior Validation Manager

    2 weeks ago

    Melbourne, Victoria, Australia beBeeValidation Full time $180,000 - $200,000

    Job DescriptionThe Process Validation Specialist is responsible for ensuring the operational qualification (OQ) of process equipment, guaranteeing that all processes meet industry standards and regulatory requirements.This role involves leading Operational Qualification (OQ) activities for process equipment, focusing on filling and protein processing...

  • Aged Care Service Manager

    1 week ago

    Melbourne, Victoria, Australia beBeeCare Coordinator Full time $60,000 - $80,000

    Key Responsibilities:This role requires the management of in-home care services, ensuring high-quality care is delivered to clients while maintaining compliance with relevant laws and professional standards.The ideal candidate will have a Certificate III in Aged Care or higher qualification and possess knowledge of the aged care industry and community...

  • Validation and Commissioning Professional

    1 week ago

    Melbourne, Victoria, Australia beBeeQuality Full time $100,000 - $150,000

    Job Title:Senior Commissioning, Qualification, and Validation (CQV) EngineerKey Responsibilities:Lead CQV functions, reports, and processes.Implement safety programs for major capital projects.Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.Initiate, author, revise, review, and complete controlled documents for...

  • CQV Validation Specialist

    1 week ago

    Melbourne, Victoria, Australia beBeeBiotechnology Full time $120,000 - $140,000

    Job RoleAs a CQV Professional, you will work alongside our talented team in an exciting and diverse biotechnology landscape.Key Responsibilities:Commission, qualify, and validate facilities, equipment, and utilities in assigned projects.Responsible for protocol writing and execution - Draft, execute, review, and approve validation documentation ensuring the...

  • Pharmaceutical Facilities Validator

    2 weeks ago

    Melbourne, Victoria, Australia beBeeValidation Full time $130,000 - $180,000

    Job Title: Senior Pharmaceutical Commissioning Qualification Validation EngineerRole Overview:We are seeking a highly experienced and skilled Senior CQV Engineer to join our team in Melbourne, Australia.The successful candidate will be responsible for developing comprehensive documentation to support the commissioning, qualification, and validation of...