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Process Design Specialist

3 weeks ago


Cork, Cork, Ireland beBee Careers Full time
Process Design Specialist

Purpose

We are seeking a highly experienced Process Design Specialist to provide process engineering services in support of the design and commissioning & qualification of a significant expansion to an existing bulk vaccine processing facility.

The successful candidate will be responsible for managing cross-functional teams to deliver the following scope:

  1. Equipment package design, factory acceptance testing, installation and commissioning.
  2. Packages may include Product Vessels, Single Use Mixers, Single Use UFDF skids & CIP/SIP skids.
Key Responsibilities
  1. Support GES Process Lead to develop and implement a Process Design based on the scope of Process Requirements outlined in the project scope of work.
  2. Lead cross-functional project teams to ensure that project and site stakeholder inputs and requirements are clearly communicated and reflected in C&Q deliverables.
  3. Ensure that all project stakeholders are informed and consulted on key process suite activities and decisions.
  4. Monitor progress of process suite team milestones with all team members and provide regular status updates to project Tiers and stakeholders.
  5. Oversee the progression of C&Q by a partner firm.
  6. Support GES C&Q Lead to coordinate preparation and, where necessary, lead C&Q field execution.
  7. Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
  8. Manage the installation, start-up, and testing of process systems through OQ completion, interfacing with cross-functional teams to ensure systems' post-OQ (PQ, PPQ) readiness.
  9. The job holder will also undertake project engineering duties, including:
    1. Preparing project-related deliverables such as schedules, work plans, and equipment cost tracking.
    2. Coordinating project activities between stakeholders.
Requirements
  1. 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 elements of chemical/biochemical engineering fundamentals as applied to biotechnology/bioprocessing.
  2. Minimum of 8 years of post-academic process engineering experience in relevant biopharmaceutical processing design, construction & start-up environment.
  3. Demonstrated ability to lead/influence teams in a matrix team environment.
  4. Excellent communication, presentation, and organizational skills.
  5. In-depth understanding of process engineering and technologies pertinent to unit process and utility operations for a bulk vaccine/biologics processing facility.
  6. Knowledge on the application of single-use technologies.
  7. Knowledge of DCS/PLC process control platforms and industry SDLC methodology such as Delta V.