• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • North Valley Business Centre, Cork, T23 KC67, Ireland     +353 21 206 6178     info@prochem.ie
  • Process Development Engineer – Co. Wicklow

    Role Purpose:


    • Our client has an immediate vacancy for a Process Development Engineer to support their Manufacturing Sciences Department during a busy period of NPI/ Tech transfer projects on their site in Co. Wicklow.
    • The department is responsible for Tech transfers of new products as well as supporting and improving existing processes in a pharmaceutical plant operating to HPRA and FDA standards.
    • Hybrid working; depending on training and project activity some weeks will be 100% site based and some weeks ~50:50.


    Core Duties and Responsibilities:


    • Provide a new product introduction and process development service to manufacturing operations in Processing, Tabletting and Packaging.
    • Introduction of new products, materials and technologies; the discovery of process improvement opportunities and the re-development of legacy processes to increase productivity, reduce manufacturing costs and eliminate quality defects.
    • Lead projects including technical transfers and post approval product lifecycle change management. Lead and execute early-stage feasibility, technical, process optimisation and process validation studies.
    • Specific ongoing and upcoming projects include:
      • Multiple new drug product introduction on new process equipment
      • Strategic products hypercare and process support
      • Roll-out of new digital tools: Discoverant for CPV and KNEAT for paperless validation
    • There are other projects and initiatives in the planning stage and the Process Development Engineer is expected to be flexible with regard to project assignment.
    • The candidate is expected to liaise with local site and global company SMEs regarding best technical solutions, change management, production and quality system readiness and project implementation strategy.


    Education & Qualifications Required:


    • Degree in Science/ Engineering required, ideally a Masters.
    • Minimum of 3 years experience as a Process Engineer.
    • Extensive experience in the pharmaceutical sector required.
    • Excellent project management skills with the ability to manage multiple projects simultaneously required.
    • Experience in Tech Transfer and Process Validation desirable.
    • Experience with Veeva, SAP, Pilot Lab and Digital CPV Program would be an advantage.
    • The candidate should have a good understanding and experience of the following key areas:
      • Feasibility / Project plan / Stakeholder engagement
      • Project team set up / cross functional communication / chairing & recording meetings
      • Project reporting and Schedule management
      • GMP change management and risk assessment
      • Cross-functional team leading
      • Trial and process validation study execution
      • Doc authoring for Regulatory submissions
      • Completion / training / handover
      • Operations, process / technical support / Hypercare


    To Apply: Quote – PE23070


    If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:

    14 Danville Business Park, Kilkenny, R95 F727, Ireland.
    +353 56 77 90100

    Click here to submit your CV

    Please note, we do not require agency assistance with this role.