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

• 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.