Senior Process Engineer (Client Side)

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.