11 month contract Vaccine manufacture - Cork Senior CQV/Process Engineer AMC22628 I am on the look out for an experienced Process Engineer to support design and C& of a significant expansion of an existing vaccine manufacturing facility based in Cork The ideal candidate would have 8+ years experience in Process Engineering/CQV including Equipment package design, factory acceptance testing, installation and commissioning.
You will manage teams working on Product Vessels, Single Use Mixers, Single Use UFDF skids & CIP/SIP skids.
Job Responsibilities: Support 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.
Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the 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 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. Apply today or get in touch with Angela McCauley at Life Science Recruitment for more information.
Skills: CQV Process Engineering Commisioning and Qualification