Senior Process Engineer

ref. 01251

Senior Process Engineer

Asset Recruitment is recruiting a Senior Process Engineer, on behalf of our client, a leading pharmaceutical Company located in Brinny, Co. Cork.

Role

Reporting to the Director of Engineering, you will be responsible for introducing new processes and/or products (product transfer), developing and transferring knowledge of Lean Six Sigma, Change Management and Inclusion. Providing 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 delivering 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.

In this role, you will guide and participate in cross-functional investigations on problems/deviations, including defining corrective and preventive actions. Identify, analyse and prioritize technical or business-related processes and issues, initiating and coordinating improvements. Contribute to a data driven decision making process and ensure effective application of Lean Six Sigma 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.

Responsibilities

1. 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.
2. Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in C&Q deliverables.
3. Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
4. Oversee C&Q progression by a partner firm.
5. Ensure site engineering standards, procedures and practices are being followed.
6. 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.
7. Manage installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems' post-OQ (PQ, PPQ) readiness.
8. Undertake Project Engineering duties including preparation of project related deliverables such as schedules, work plans, equipment cost tracking coordination of project activities between stakeholders.
9. Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites as required to support Project.

Requirements

1. 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.
2. 8 years+ post academic process engineering experience in relevant Biopharmaceutical processing design, construction & start-up environment.
3. Demonstrated ability to lead/influence teams in a matrix team environment.
4. Knowledge of DCS/PLC process control platforms and industry SDLC methodology such as Delta V.
5. Deep understanding of process engineering and technologies pertinent to unit process and utility operations for a bulk vaccine/biologics processing facility.
6. Knowledge on the application of single use technologies.
7. Strong communication/presentation/organizational skills.