Senior/ Lead Equipment Engineer (Drug Product Sterile Filling)

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company focused on the development of cell therapies for a broad range of cancers.

Tessa’s clinical pipeline derives from  two innovative cell therapy platforms; CD30 Chimeric Antigen Receptors (CD30-CARs) and Virus-Specific T cells (VSTs). Our lead candidate comprises autologous CD30 CAR-T cell therapy targeting classical Hodgkin lymphoma (cHL) and CD30+ non-Hodgkin lymphomas.

Tessa is also developing a novel, allogeneic platform technology, as a new approach to traditional cell therapy. By combining the unique properties CD30-CARs and VSTs, the platform holds potential for the creation of next-generation off-the-shelf cell therapies against a variety of hematologic malignancies and solid tumors.

Tessa’s state-of-the-art GMP cell therapy manufacturing facility will open in early 2021, and will substantially enhance in-house production capabilities. Tessa is focused on rapidly and reliably providing safe, effective treatment options for patients.

Job Position
Senior/ Lead Equipment Engineer (Drug Product Sterile Filling)

 Job Description

  • Support start-up activities, commissioning and handover of equipment & systems from project to users/ operation.
  • Provide operational support in terms of the following:
    • Reliability and maintenance of process equipment for Fill and Finish line
    • Support product yield improvement projects
    • Ensure maximum machine uptime
    • Lead/ support investigations, change controls and CAPAs
    • Draft/ review/ approve GMP documents
  • Manage external contractors in the areas of System, Equipment and Rooms for Calibration and Maintenance
  • Ensure maintenance and service contracts are executed as per requirements; establish regular review points with external contractors as required to continually improve processes and performance
  • Ensure that work carried out on site adheres to site EHS and quality procedures
  • Work cross functionally to ensure Systems, Equipment and Rooms meet Internal Customers’ needs
  • Advocate and support EHS initiatives

Requirements

  • Diploma or Degree in an engineering discipline with minimum 7 years of working experience
  • Prior experience with Fill and Finish equipment will be a plus
  • Familiar with Microsoft project or other planning tools
  • Able to work in a multi-cultural, fast-paced environment with minimum guidance
  • Has prior experience leading teams but is also able to leverage on cross functional support
  • Experience managing both internal and external stakeholders
  • At least 5 years of relevant experience in managing contractors in cGMP facility operations
  • Experience in cGMP requirements is a must
  • Willing to learn, self-starter and continuously improve
  • Good communication and interpersonal skills
  • Knowledge in Bio-Pharma R&D is an added advantage