The role, will be working at our clients site in Brinny which is situated in Cork in South West Ireland. The site is just 30 minutes drive from the centre of Cork and is accessible by bus too.
Our client has a long history of pushing the boundaries of science in order to help fight some the worlds most urgent global health challenges. This role is based at a state of the art biologics operation where they formulate and fill vaccines and biologic products.
The successful candidate will provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility. It will involve working with the Process Engineering Team to act as client owner representative to deliver integrated process engineering services to meet the Project Objectives. The Senior Process Engineer will manage cross functional teams to deliver a significant suite or multiple suites of related process scope.
- Support Process Lead to implement a Process Design based on the scope of Process Requirements provided by the Technology and Manufacturing owners.
- Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
o Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
o Monitor progress of process suite team milestones with all team members and provide status reports to project Tiers and stakeholders.
- Act as client owner representative to self-execute critical design deliverables and provide direction and oversee design progression by an Architect and Engineering design firm.
o Develop Process Flow Diagrams, P&IDs, User Requirement Specifications and Equipment Specifications to ensure Process Descriptions/Needs are met.
o Manage team to complete process safety deliverables including PHA (Hazops).
o Ensure site engineering standards, procedures and practices are followed in the design development.
- Support C&Q Lead to coordinate preparation and lead FATs/C&Q field execution.
o Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation and C&Q documentation.
o 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 Manufacturing Network as required to support Project.
- On occasion, the job-holder may also undertake Project Engineering duties including:
o Preparation of project related deliverables such as schedules, work plans, equipment cost tracking.
o Coordination of project activities between stakeholders.
- Minimum qualification BSc or MSc/MEng 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 sterile or aseptic manufacturing.
- Minimum of 8 years post academic process engineering experience in relevant aseptic/sterile processing design, construction and start-up environment.
- Demonstrated ability to lead/influence teams in matrix environment.
- Excellent communication/presentation/organisational skills.
- In depth understanding of process engineering and technologies pertinent to unit operations including Closed-Process Formulation, Depyrogenation Tunnel, Isolated Filling, Capping, Automated Parts Washing, Autoclave Sterilization, Mobile Process Vessels, Bioburden reduction/Sterile Filtration, and CIP/SIP.
- Knowledge on the application of Disposable Technologies.
- Knowledge of PLC process control platforms and industry SDLC methodology.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45898 in all correspondence.
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