• 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
  • Clean Utilities Process Engineer – Co. Carlow

    Role Summary:

     

    • A vacancy has arisen for an experienced Clean Utilities Process Engineer at our client’s pharmaceutical site in Co. Carlow.
    • Provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility.
    • The jobholder works with the site Process Engineering Team to act as client owner representative to deliver integrated process engineering services to meet the Project Objectives.
    • The Clean Utilities Process Engineer will manage technical package deliverables for Clean Utilities package for a Drug Product Fill Finish project and participate in cross functional teams to deliver on objectives.

     

    Core Duties and Responsibilities:

     

    • Support GES Process Lead and GES Suite Team Lead to implement a Clean Utilities Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.
    • Lead technical package ownership for the Clean Utilities package and facilitate cross-functional interactions to ensure project and site stakeholder inputs are reflected in vendor design deliverables.
      • Drive resolution of technical issues and escalate risks to the Process Lead and Suite Team Lead.
      • Ensure all project stakeholders are informed and consulted on key clean utilities suite activities and decisions.
      • Monitor progress of package technical milestones with all team members and provide status reports to project Suite, Process Lead and Tiers.
    • Act as client owner representative to self-execute critical deliverables and oversee other deliverable by an Architect & Engineering design firm.
      • Own package technical deliverables including User Requirement Specifications, Equipment Specifications, PHA (HAZOP) Action.
      • Ensure Global and Local engineering regulations are followed for packages.
    • Support GES C&Q Team with FATs/C&Q readiness with document preparation and field execution.
      • Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
      • Manage vendor efforts for installation / start-up / testing of process systems through PQ completion and start-up.
    • Liaise with SMEs at other sites within the site Manufacturing Network as required to support Project.
    • On occasion, the jobholder may also undertake Project Engineering duties including:
      • preparation of project related deliverables such as schedules, work plans, equipment cost tracking
      • coordination of project activities between stakeholders

     

    Minimum Qualifications and Experience:


    • Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in Chemical or Biochemical Engineering or equivalent discipline; equivalent is defined as a Biotechnology or Industrial Chemistry Degree with the basic elements of chemical / biochemical engineering fundamentals as applied to sterile or aseptic manufacturing.
    • Minimum of 6 years post academic process engineering experience.
    • Experience in leading Clean Utility system design, including Water for Injection, Clean Steam, Clean Dry Compressed gasses.
    • Knowledge of WFI and CS equipment and system design
    • Knowledge of hygienic system design
    • Awareness of sterile drug product unit operation and sterile support/formulation systems is preferred.
    • Demonstrated ability to lead / influence teams in matrix environment
    • Excellent communication/presentation/organizational skills
    • Knowledge of PLC process control platforms and industry SDLC methodology

     

    To Apply:

     

    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, Ireland
    +353 56 77 90100
    recruitment@prochem.ie

    Click here to submit your CV

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