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

    Role Summary:


    • Our clients is looking for a dedicated Process Engineer to drive the production aspects of introducing a new suite of pharmacautical/biopharmaceutical products.
    • These products will be liquid formulations filled into single-use bags in a Class D environment.
    • The role involves working closely on the ground with production personnel and supporting departments to design the process, prepare and execute test protocols, organise the production process equipment layout, co-ordinate samples and materials through warehouse/production, and liaise with the program manager and other departments.
    • The project will require a full-time engineer for 12 months and is a tremendous opportunity for an ambitious hands-on engineer to become a core team player in a small team working to an ambitious launch date.
    • All work to be carried in compliance with cGMP and our clients standard operating procedures and policies.


    Core Duties and Responsibilities:


    • Attending weekly meetings to review items on NPI schedule.
    • New code request forms – preparation and review.
    • Review/approve New Process Introduction documentation.
    • eDoc review of method validation/verification protocols/reports in eDoc.
    • Operations Department review of new Master Batch Records/Cleaning records.
    • Prepare/request/set-up new labels.
    • Design process for sterile filter integrity tests.
    • Co-ordinate Process Fill and Mixing Process Validations, and Cleaning Validations including co-ordination of protocol samples through Production group.
    • Involvement in change controls/cGMP and EHS Risk Assessments.
    • Training production operators on the new process.
    • Troubleshooting initial batches through the plant and dealing with issues as they arise.
    • Attending process design meetings.
    • Attending Process and System Training.
    • Assisting with development of BOMs.
    • Performs any other duties as outlined by the Supervisor or Departmental head.




    Minimum Qualifications and Experience:

    • Bachelor’s Degree in Engineering or Science preferably Chemical or Mechanical.
    • Previous project management experience with New Product Introductions, preferably working in the Bulk Pharmaceutical or Biopharmaceutical industry.
    • Previous experience with aseptic filling would be advantageous.
    • Some competence in the use of Inventory Management systems (eg SAP©, barcode systems) with proven numerical and literacy skills.
    • Competence in writing and reviewing cGMP documentation.
    • Previous hands-on project management experience in the Pharma/Biopharma sector would be a distinct advantage.
    • The role involves working closely with other departments so must be able to work in a team.
    • Computer literate.
    • Pragmatic approach to problem solving
    • Mature judgment, problem solving and decision-making ability.
    • Ability to identify, develop and deliver on process improvement opportunities.
    • Energetic committed individual who is used to working to tight deadlines and can work in a flexible way when necessary.
    • The successful candidate will have proven project management experience and will be self-motivated to drive the project to a successful on-time launch date.


    To Apply:

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

    Click here to submit your CV

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