• 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 – Co. Carlow

    Role Summary:

     

    • A vacancy has arisen for an experienced Process Engineer at our client’s pharmaceutical site in Co. Carlow.
    • The successful candidate will 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 Process Engineer will manage package deliverables forming part of the scope for a Drug Product Fill Finish project and participate in cross functional teams to deliver on objectives.
    • The Process Engineer will be responsible for discreet equipment packages that include GMP Parts washing, Sterilization Autoclave, VHP Material transfer systems, Sanitary Process Equipment and Single Use Formulation systems.

     

    Core Duties and Responsibilities:

     

    • Support GES Process Lead and GES Suite Team Lead to implement a Process Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.
    • Lead package ownership for the agreed packages and facilitate cross-functional interactions to ensure project and site stakeholder inputs are reflected in vendor design deliverables.
      • Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
      • Monitor progress of package milestones with all team members and provide status reports to project Suite 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 site Global and Local engineering standards, procedures and practices 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.
    • 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, Mechanical or Biochemical Engineering or equivalent discipline; equivalent is defined as a Biotechnology or Industrial Chemistry Degree with the basic elements of chemical/mechanical/ biochemical engineering fundamentals as applied to sterile or aseptic manufacturing.
    • Minimum of 6 years post academic process engineering experience.
    • Awareness of sterile drug product unit operation and sterile support/formulation systems is preferred.
    • Knowledge of Sterile Drug Product processes
    • Knowledge of hygienic/sterile process system design
    • 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.