• 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 – Cork

    Role Summary:

     

    • Provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility.
    • The job-holder works with the Process Engineering Team to act as client owner representative to deliver integrated process engineering services to meet the Project Objectives.
    • The Senior Process Engineer will manage cross functional teams to deliver a significant suite or multiple suites of related process scope.

     

    Core Duties and Responsibilities:

     

    • Support GES Process Lead to implement a Process Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.
    • Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design 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.
    • Act as client owner representative to self-execute critical design deliverables and provide direction & oversee design progression by an Architect & Engineering design firm.
    • Develop Process Flow Diagrams, P&IDs, User Requirement Specifications and Equipment Specifications to ensure Process Descriptions/Needs are met.
    • Manage team to complete process safety deliverables including PHA (Hazops).
    • Ensure MSD Global and Carlow site engineering standards, procedures and practices are followed in the design development.
    • Support GES C&Q Lead to coordinate preparation and lead FATs/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 MSD Manufacturing Network as required to support Project.
    • On occasion, the job-holder 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.
    • This is a contract position. Estimated assignment duration is approx. 24-36 months, with initial 12 month contract.
    • The position is based at the MSD Brinny Site for detailed design, execution and qualification activities.
    • Location may be flexible between Brinny and AE location (TBC) during earlier design phase.
    • The role will require periods of travel to support vendor reviews & FATs, and periodic attendance at Architect & Engineering Firm offices (location TBD). Flexibility is required in this regard.

     

     


     

    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 sterile or aseptic manufacturing.
    • Minimum of 8 years post academic process engineering experience in relevant aseptic/sterile 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 operations including Closed-Process Formulation, Depyrogenation Tunnel, Isolated Filling, Capping, Automated Parts Washing, Autoclave Sterilization, Mobile Process Vessels, Bioburden reduction/Sterile Filtration, and CIP/SIP.
    • Knowledge on the application of Disposable Technologies.
    • 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:
    recruitment@prochem.ie

    Click here to submit your CV

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