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Validation Specialist

Act as  a critical technical resource for our plant expansion program. As part of the project team, you will be responsible for ensuring all equipment and computer systems are qualified and processes are validated as required.

Responsibilities

    • Executing FAT/SAT/Installation & Commissioning/Validation to agreed timelines.
    • Development of validation protocols  for new production suite and training/education of all relevant internal staff on protocols.
    • Support execution phases of the scale-up project (validation, start-up, ramp-up) in coordination with Operations, Technical services, Quality and RA
    • Comprehensive mixing studies, establishing validated conditions (duration, mixing speed, temperature, etc.)
    • Filtration validation (fit for use for process conditions, retention, binding, compatibility, etc.)
    • Ensure preparation, review and approval of protocols and reports as per project schedule
    • Author and review technical and documents including but not limited to commissioning and qualification plans, validation plans, protocols and reports and Standard Operating Procedures (SOP).

Qualifications

    • Bachelor of Science degree or equivalent, ideally Chemistry, Biology, or Biochemistry.
    • 2+ years  in GMP environment
    • Knowledge of IQ, OQ, PQ
    • Demonstrated ability to write complex documentation
    • Solid understanding of validation requirements
    • Proficiency in computer applications, specifically Microsoft Office

Application Process

Application process: Please send your resume using the form below.

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