Contract: Technical Engineering Engineer / IrelandClick here to shortlist this job 1-CLICK Apply With Employer or Register Now
The client is currently recruiting a Technical Engineering Engineerto work on a 11-month contract.
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.
- 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.
- Execution of equipment commissioning and qualification programs.
- Execution of equipment/qualification validation programs; including re-qualification and revalidation.
- 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 investigations
- 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.
- Serve as technical engineering representative for internal technical group discussions and represent the company at global technical forums.
- Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
QUALIFICATIONS, SKILLS & EXPERIENCE REQUIRED
- 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.
- Ability to lead/mentor team of engineers
- Align on-site and off-site function
- Design & develop engineering studies
- Lead technical transfer
- Lead C&Q or validation studies