Engineering & Electronics
Responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction. Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities. Co-ordination, design and execution of equipment qualification. and validation as required.
- Serve as technical and/or validation support as required for manufacturing and new product introduction.
- Project validation support including conducting equipment performance qualifications (specifically cleaning and sterilization validation)
- Authoring project validation master plans; SOP and documentation updates
- Authoring validation protocols and final reports, executing validation studies, analysis of validation data; Resolving technical issues encountered during study execution.
- Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
- Provide technical input into quality notification by authoring/reviewing/approving investigations.
- Execution of equipment commissioning and qualification programs
- Execution of equipment/qualification validation programs; including re-qualification and re- validation
- Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process
- Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
- Support continuous improvement through Lean Six Sigma methodologies.
- Leading and active participation in projects, system failure investigations and investigation reports
- Execution/development of change controls
- Contribution to Kaizen events as appropriate.
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why’s etc.;
- Implement subsequent corrective action through the change management system.
- Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
Education and Experience:
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline with 3+ years’ relevant experience
- Would typically have prior related work experience; ideally in manufacturing, preferably GMP Setting
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Report, standards, policy writing skills required
- Equipment and process validation
- Sterile filling processes and equipment
- Proficiency in Microsoft Office and job-related computer applications required
- Lean Six Sigma Methodology experience desired
Interested candidates should submit an updated CV.
Please click the link below to apply, call Holly on 0214297900 or alternatively send an up to date CV to email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***