PE Global is currently recruiting for a Process Engineer for a leading multi-national Biologics client based in Carlow.
This is an initial 11-month contract position.
Role Summary:
Provide process engineering services in support of the design and commissioning & qualification of a significant expansion to an existing bulk vaccine processing facility. 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 Product Vessels, Single Use Mixers, Single Use UFDF skids & CIP/SIP skids.
Job 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 MSD Global and Brinny 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 MSD 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.
Education/Experience Requirements:
* 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.
* 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.
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up-to-date CV to rebecca@peglobal.net.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.***
#J-18808-Ljbffr