Quality Engineer (Aseptic Lead)

  • Contract
  • Carlow

Website Ref: TPM04306

Summary:
A Quality Engineer is required for a biopharmaceutical company in Carlow. The successful candidate will provide leadership, cross-functional development and technical expertise to operations team on the aseptic manufacture of biologics and vaccines on site. The incumbent will ensure that objectives are effectively achieved, consistent with company’s requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities:

  • Responsible for the coaching, mentoring and training of the operations teams on primary aseptic manufacturing, clean room management and behaviors on site.
  • Assess the maturity of the teams aseptic and clean room ability;
    Serve as site lead in Sterile Council and Sterile CoP and provide input to network sterile standards and guidelines.
  • Assess team member training/development needs and ensure all receive appropriate training, resources and programs to develop technical and other skills to effectively complete their jobs.
  • Develop and maintain training programs.
  • Assist the team with development of objectives and ensures alignment with site goals.
  • Foster an environment that allows for progressive, continuous improvement of skills and honest, open feedback focused on how/why to complete aseptic manufacturing process.
  • Provide ongoing formal and informal feedback on the Aseptic qualification of the operations team.
  • Oversee coordination of resources to implement suggestions/ideas of merit within the clean room areas.
  • Effectively lead the media fill (Process Simulation) development and execution.
  • Responsible for contributing to the Cleanroom Operation and contamination control procedures in operations including but not limited to: Cleaning and Sanitisation, Garbing, People, Material and Process Flow, and Segregation Procedures.
  • Required to comply with the companies Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture in Carlow site.
  • May be required to perform other duties as assigned.

Qualifications & Experience:

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
  • 5 years’ operations experience in a sterile manufacturing environment.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.