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Contact Info
Alexa Tralla
Life Science

+353 1 507 9255
alexa.tralla@lifescience.ie
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Details

Process Engineer (Contract)


Reference:AT/HQ00001878 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:Temporary ContractSalary: Not Disclosed
May be suitable for: Process Engineer, Bioprocess Engineer

Job Title: Process Engineer

Job Purpose

Provide process scientific, manufacturing technology and validation support for the tech transfer, including knowledge capture, execute demonstration / engineering batches, execute cleaning and process validation, support site operational readiness ( new materials introduction, method transfer, operational training etc. ) and support filing submissions.

Job Responsibilities:

  • Capture knowledge from donating site through review of documentation, compiling process descriptions and flow diagrams, interacting and training with donating site personnel.
  • Prepare and execute process and cleaning validation protocols. Write up the associated reports.
  • Provide process expertise to support from preliminary engineering through to the end of process & Cleaning validation and delivery of the facility to Operations.
  • Lead major process investigations as requested and support the implementation of CAPAs
  • Capture the all aspects of the existing process and equipment at the donor sites to ensure that an equivalent process is started up at Grange Castle
  • Participate in Gap Analyses and Risk Assessments to support the tech transfers
  • Participate in facility and equipment design and qualification to support the tech transfers
  • Liaise with site functions – logistics, planning, QA, QC, Operations, Regulatory Affairs to support the process transfer to GC
  • Liaise with Suite 4 & 5 operations – to co-ordinate the tech transfer activates with on-going commercial operation in multiproduct environment.
  • Model the running of the facility with Operations – number of batches, scale of equipment, facility sizing and layout, etc
  • Write Tech Transfer Documents Carry out process monitoring of batches processes and work to improve process capability where weaknesses are identified.
  • Help maintain the process model/mass balance for the processes
  • Write product/process impact assessments in support of investigation closures, as requested.
  • Work to implement a culture of Right-First Time through partnerships with Operations and other functions on site and provide leadership in the use of OE principles to optimise our technical and business processes.
  • Ensure the process automation meets the requirements of the process
  • Assist in the raising and execution of change controls for Technical Services
  • Generate and own site Process Descriptions, Process Parameter classifications and Process Flow Diagrams (PFDs).
  • Provide technical training on process and technology areas as required by the project.
  • Support Compliance Inspections and enquiries from Regulatory Agencies.
  • Develop and maintain productive links with process equipment & technology supplier and vendors.

Experience



  • A minimum of 8-10 + Years’ experience in biopharmaceutical or pharmaceutical cGMP manufacturing environment, or equivalent, with a background in chemical processing operations cGMP industrial experience, ideally covering Operations, Engineering, Projects or Validation within bioprocess manufacturing.
  • Experience of process and / or cleaning validation execution preferred.
  • An understanding of processes including biotechnology, purification technology and unit operations ultrafiltration, chromatography, Activation/Conjugation potential impact of equipment on biological molecules.
  • Experience working with automated control systems. (Delta V, Unicorn)
  • Experience with technology transfer and project engineering preferred.
  • Experience in Quality Control / analytical methods and associated tech transfer.
  • Experience of FDA and EU licensing and inspection preferred.
  • Demonstrated aptitude for technical learning and problem solving.

Education



  • Minimum qualification of a B. Sc. Degree in Bioprocess Science, Biotechnology, Engineering or equivalent with particular emphasis in Biochemical, Chemical or Mechanical discipline.