- We are looking for a Process Equipment SME for the client project management team for a €325 Million Biologics greenfield manufacturing facility in Dundalk.
- Reporting to manufacturing building project manager, manage all the design and installation of process equipment.
- Provide day to day support and coordination during the full cycle of design, build, and C&Q.
- The equipment engineer will be responsible for the full life cycle of the project from concept to completion.
- Liaison with the manufacturing, engineering, QC and QA functions in other sites to define the user’s requirement and transfer the knowledge to the engineering firm and vendors.
- Lead design, build, commissioning and qualification of manufacturing facilities and systems of biopharmaceutical therapeutics.
- Lead capital and non capital projects, and process engineering function insight into the equipment, processes, and operations requirements.
- Establish technical support initiatives for GMP operations in a multi-product cell culture and purification facility.
- Lead cross-functional project teams to ensure specific unit operation requirements are implemented and tested in C&Q deliverables.
- Develop and/or review system lifecycle documents including 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) readiness.
- Ensure all project stakeholders are informed and consulted on key process activities and decisions.
- Act as client representative to ensure that critical design deliverables are provided and provide direction & oversee design progression by Engineering Design Team.
- Ensure that all relevant engineering standards, procedures and best practices are followed.
- Ensure Design Risk Assessments and HAZOPs are performed.
- Chartered Engineer.
- Bachelor degree in Chemical or Process Engineering.
- More than ten (10) years proven engineering experience with at least 8 years within the pharmaceutical, biotech, life sciences industries or engineering firm is required.
- Strong project management skills with Good Communications Skills.
- Good time management skills and ability to work in fast pace environment.
- Hands-on experience in process equipment for the biotech industry.
- Familiar with safety rules and regulations as per national and other applicable agencies, such as FDA, EMA and HPR.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100