• 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
  • Validation Engineer – Co. Wicklow

    Role Purpose:


    • Our client based in Co. Wicklow has an immediate requirement for a Validation Engineer to support their Manufacturing Sciences Department during a busy period of NPI/ Tech transfer projects on the site.
    • 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 validation SME input and oversight to new product introduction and process development activities in manufacturing operations in Processing, Tabletting and Packaging.
    • This includes the 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.
    • Be the validation lead for these changes from an execution and oversight perspective:
      • 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: KNEAT for paperless validation
    • There are other projects and initiatives in the planning stage and the Validation 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 change management, validation strategy and regulatory activity.


    Education & Qualifications Required:


    • Degree in Science/ Engineering required, ideally a Masters.
    • Minimum of 3 years experience as a Validation Engineer (oversight and execution) with extensive experience in the pharmaceutical sector required.
    • Experience in Process, Cleaning Hold Time Validation and Pharm Oral Solid Dosage (SOD) required.
    • Experience with Veeva, SAP, Trackwise, KNEAT would be an advantage.
    • Excellent project management skills with the ability to manage multiple projects simultaneously.
    • The candidate should have a good understanding and experience of the following key areas:
      • Validation strategy definition
      • Validation SME from process and product perspective
      • Validation SME assessments of GMP change controls and risk assessments
      • Validation study execution and oversight
      • Audit support
      • Doc authoring for Regulatory submissions


    To Apply: Quote – PE23069


    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.