Description:
Our Engineers support internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
Responsibilities
- Design/Author/Review/Approve/Execute qualification/validation documentation, process development studies and change control in line with the standard approval process.
- Contribute to Kaizen events as appropriate
- Technical input into quality notification by authoring/reviewing/approving investigations
- Execution of equipment/qualification validation programs; including re-qualification and re-validation
- Support continuous improvement through Lean Six Sigma methodologies.
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
- Serve as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forums.
Requirements
- Bachelors degree
- 3 years experience in GMP environment including Process Engineering experience
- Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment (desirable)
- Equipment and process validation
- Sterile filling processes and equipment
- Demonstrable experience of leading technical related projects