• 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
  • Senior Process Engineer – Co. Cork

    Role Summary:

     

    • A new opportunity has arisen for a Senior Process Engineer to join our client’s pharmaceutical site in Co. Cork.
    • Provide process engineering services in support of the design and commissioning & qualification of a significant expansion to an existing bulk vaccine processing facility.
    • The job-holder works with the Process Engineering Team as a client owner representative to deliver Project Objectives.
    • The Senior Process Engineer will manage cross functional teams to deliver the following scope;
      • Equipment package design, factory acceptance testing, installation and commissioning
      • Packages may include Autoclave, COP/SOP skid, WFI storage and distribution, Downflow Booth, Glovebox modifications, wave rockers and miscellaneous ancillary equipment.

     

    Core Duties and Responsibilities:

     

    • Support GES Process Lead to implement a Process Design based on the scope of Process Requirements outlined in the project scope of work.
    • Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in C&Q deliverables.
      • Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
      • Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
      • Oversee C&Q progression by a partner firm.
      • Ensure Global and Co. Cork site engineering standards, procedures and practices are followed.
    • Support GES C&Q Lead to coordinate preparation and, at times, lead C&Q field execution.
      • Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
      • Manage installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
    • Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the site Manufacturing Network as required to support Project.
      • The job-holder will 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 basic the elements of chemical/biochemical engineering fundamentals as applied to biotechnology/bioprocessing.
    • Minimum of 7 years post academic process engineering experience in relevant biopharmaceutical processing design, construction & start-up environment.
    • Demonstrated ability to lead / influence teams in matrix environment
    • Excellent communication/presentation/organizational skills
    • In depth understanding of process engineering and technologies pertinent to unit process and utility operations for a bulk vaccine processing facility.
    • Knowledge on the application of single use technologies
    • Knowledge of DCS/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:

    GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland.

    +353 21 2066178
    recruitment@prochem.ie

    Click here to submit your CV

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