Biopharmaceutical Process Design Lead

2 weeks ago


Cork, Cork, Ireland Recruitment By Aphex Group Full time
Job Description

Job Title: Senior Process Engineer

Company Overview:

Recruitment By Aphex Group is seeking a skilled Senior Process Engineer to provide process engineering services in support of the design and commissioning & qualification of a significant expansion to an existing bulk vaccine processing facility.

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.
  • 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.

Qualifications:

  • Bachelor's or Master's Degree in Chemical or Biochemical Engineering or equivalent discipline;
  • Minimum of 8 years post-academic process engineering experience in relevant biopharmaceutical processing design, construction & start-up environment.
  • Demonstrated ability to lead / influence teams in a matrix team 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/biologics processing facility.
  • Knowledge on the application of single use technologies;
  • Knowledge of DCS/PLC process control platforms and industry SDLC methodology such as Delta V.


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