CPL Recruitment: Tech Services Engineer

As a result of investment and expansion, my client is undertaking a large project to retrofit and install new production and manufacturing lines to increase capacity on site.

This has created an urgent need for 4 Tech Services Engineers, with an additional 10 requirements identified to commence work between October and January. All vacancies will be filled before September, and the start dates will vary.

Process Scientists and Process Engineers, with Tech Transfer, Validation, Commissioning and Verification Experience are highly desirable.

The role focuses on facility and equipment design, process knowledge capture from donor sites, assisting in technology transfer execution including process trials at scale in support of these project objectives and execution of final process validation and cleaning validation studies and write-ups.

Contract:

  • Hourly pay rate
  • Suitable for either Ltd Liability contractors or PAYE temporary agency workers
  • 12 month contracts initially, with potential for extension

Responsibilities:

  • Carry out process tranfers to site
  • Capture knowledge from donating site through review of documentation, observation of batches, compiling process descriptions and flow diagrams, interacting and training with donating site personnel
  • Participate in Gap Analyses and Risk Assessments
  • Capture all aspects of the existing process and equipment at the donor sites to ensure that an equivalent process is transferred and validated at large scale. 
  • Develop and maintain mass balances and process flow diagrams (PFDs) for new processes
  • Develop site documentation
  • Review and approve process equipment designs, layouts, automation and piping and instrumentation diagrams (P&IDs)
  • Assist in the development of the Bill of Materials (BOM) and Sampling Plan for new processes.
  • Develop user requirements specifications (URS) for process equipment
  • Provide technical process input to the equipment verification process.
  • Carry out process transfer and validation risk assessments
  • Write up process validation summary reports
  • Develop cleaning cycles for new process and equipment
  • Design and execute Filter Validation and Shipping Validation studies
  • Lead major process investigations
  • Write product/process impact assessments
  • Raise and execute change controls

Experience Required:

  • 4+ years cGMP industrial experience
  • Strong, demonstrable technical problem solving
  • Ideally, experience in Tech Transfer methodologies and execution
  • Ideally, knowledge of mammalian cell culture processes and/or their purification technologies
  • 3rd level qualification, ideally in a biochemical, chemical or biological discipline. BSc minimum.

To apply:

To apply for this position, please contact Jenny Navan via phone 00353 1 6146072 or via email Jenny.Navan(at)cpl.ie

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