Senior Process Engineer
We are seeking a Senior Process Engineer to join our client, a leading pharmaceutical company, located in Brinny, Co. Cork.
Role
As a Senior Process Engineer, you will report to the Director of Engineering and be responsible for introducing new processes and/or products (product transfer), developing and transferring knowledge of Lean Six Sigma, Change Management, and Inclusion.
You will provide process engineering services in support of the design and C&Q of a significant expansion to an existing bulk vaccine processing facility. You will be part of the Process Engineering Team as a client owner representative to deliver Project Objectives, managing cross-functional teams in the delivery of 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.
Responsibilities
* Support the Global Operation 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.
* 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 site engineering standards, procedures, and practices are being followed.
* Support C&Q Lead to coordinate preparation and, at times, lead C&Q field execution and 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.
* Undertake Project Engineering duties including preparation of project-related deliverables such as schedules, work plans, equipment cost tracking coordination of project activities between stakeholders.
* Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites as required to support Project.
Requirements
* 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.
* 8 years+ post-academic process engineering experience in relevant Biopharmaceutical processing design, construction, and start-up environment.
* Demonstrated ability to lead/influence teams in a matrix team environment.
* Knowledge of DCS/PLC process control platforms and industry SDLC methodology such as Delta V.
* Deep 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.
* Strong communication/presentation/organizational skills.