Senior Process Engineer

Senior Process Engineer

PROCHEM Engineering

Cork, Ireland

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.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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