Manufacturing Systems Engineer
The Manufacturing Systems Engineer is to be primarily responsible for the delivery of the approved site programmes relating to manufacturing systems and technology development including, but not limited to, serialisation, automation improvements, sustainability, engineering systems and operations digitalisation and development to the site.
Key Responsibilities:
- Design, Procurement, Installation, Commissioning, and validation of manufacturing equipment and processes under the site change control system.
- Lead the generation of lifecycle documentation for equipment and associated systems.
- Design and enable Digital Technologies solutions on site.
- Development of URS, FDS, DDS, FAT, SAT, IQ/OQ, Risk Assessments, procedures etc for Engineering Projects.
- Collaborate significantly with internal/external functions and suppliers to finalize process and equipment design.
- Co-ordination and management of suppliers and contractors during project execution.
- Support Engineering functions, such as Factory Acceptance Testing, Commissioning, Qualification, etc. applying good project management and Engineering principles.
- Optimisation of new and existing processes to achieve production output targets.
- Act as SME for Engineering department when required.
- Carrying out project work as required by the site Capex programme or additional projects as determined.
- Ensuring that all project related documentation associated is controlled to the manner required in a cGMP environment.
The successful candidate will have
- NFQ Level 7/8/9 Degree in engineering or equivalent (degree in Automation, Mechatronics or Mechanical Engineering is preferred)
- +3 years of experience as an Engineer.
- Experience supporting a manufacturing biopharma process.
- Experience with automation industry supporting GMP environments and applications.
- Important to have a comprehensive understanding of cGMP requirements for commercial biopharmaceutical manufacturing and the ability to implement best practices (GAMP) to ensure site automation systems are cGMP compliant.
- Experience with Design, Procurement, Installation, Commissioning, and validation of manufacturing equipment and processes.
For more information please contact Clodagh D’Arcy on 01 9476356 or email details to [email protected]