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Tech Transfer Engineer, Manufacturing Technology

Job description

A global leading biopharmaceutical manufacturer is seeking a Technology Transfer Engineer to support the tech transfer, validation, and technical operations for a new product introduction. This role will be key in ensuring successful process validation, troubleshooting, and continuous improvement within a commercial-scale Multi-Product Cell Culture facility.

Key Responsibilities:

  • Lead technology transfer activities from facility assessment through PPQ execution and report completion for a new product introduction.
  • Act as an SME in Downstream Processing (DSP), including:
  • Buffer preparation, purification, chromatography, viral reduction filtration, ultrafiltration, viral inactivation, DS formulation, and bulk fill.
  • Author technical documents including validation protocols, reports, and SOPs.
  • Identify and implement process improvements to enhance yield, cycle time, and efficiency using data analytics tools.
  • Execute and oversee plant support studies and commercial-scale technical studies on the manufacturing floor.
  • Provide on-the-floor troubleshooting support, leading investigations into process deviations and resolutions.
  • Support regulatory inspections and act as a technical SME for regulatory interactions.
  • Document and communicate process learnings across internal and external scientific forums.
  • Drive process improvements through change control, CAPA, and Lean initiatives.

    Qualifications & Experience:

    • BSc or higher in a scientific or engineering discipline with 3+ years of experience in drug substance manufacturing technical support.
    • Experience in tech transfer preparation, execution, and post-execution activities.
    • Strong understanding of cGMP compliance and regulatory requirements.
    • Excellent technical writing and verbal communication skills.
    • Strong ability to collaborate across cross-functional global teams.
    • Ability to influence stakeholders and drive technical decisions balancing product quality and operational efficiency.

    Additional Information:

    • The role may require extended hours, modified work schedules, or on-call availability.
    • This is an on-site position, requiring physical presence to support collaboration, innovation, and productivity.

    What’s on Offer?

    • Exciting contract opportunity within a leading biopharma manufacturing facility.
    • Work in a highly technical and collaborative global environment.
    • Opportunity to lead tech transfer projects and drive process innovation.

    Interested? Apply today to discuss how this role could be your next career move!