your search starts here

Apply for this job

























If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box



If you are having difficulty you can always email your cv to applications@lifescience.ie

Process Engineer (Contract)

Reference:AT/HQ00001878
Location: Dublin
Qualification:Degree
Experience:10+ Years
Job Type:Temporary Contract
Salary:Not Disclosed
apply for job
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.



Apply

contact info


search


job tools

login to your account

forgot your password? click here