Summary: Our client is a biopharmaceutical company based in Cork looking for a 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.
The successful candidate will work as a client owner representative to deliver project objectives.
The 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.
Responsibilities: Responsible for introducing new processes and/or products (product transfer).
Develop and transfer knowledge of Lean Six Sigma, Change Management and Inclusion.
Steer and/or participate in cross-functional investigations on problems/deviations-including defining corrective and preventive actions.
Identify, analyse and prioritize technical or business-related processes improvement-opportunities and problems.
Initiate and coordinate improvements for technical or business processes, systems and behaviours.
Contribute to a data driven decision making process.
Ensure effective application of Lean SixSigma and Change Management tools by leading projects, facilitating kaizens and coaching sponsors and practitioners.
Minimal work direction needed, highly skilled and knowledgeable to the position.
Support the 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 site engineering standards, procedures and practices are followed.
Support 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.
Undertake Project Engineering duties including: preparation of project related deliverables such as schedules, work plans, equipment cost tracking; coordination of project activities between stakeholders.
Qualifications & Experience: 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 the 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.
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. Skills: DCS PLC SDLC methodology Delta V matrix