Process Engineer
- West
- Contract
- CAPEX Projects
With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Process Engineer to join their team to support multiple capital projects taking place onsite in Carlow.
This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US.
Role Summary:
- Lead/execute production floor-based activities.
- Plan and execute C&Q, validation activities as required.
- 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/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.
- Statistical data analysis to support development and commercialisation batches.
- 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
- 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
Requirements:
- Prior related work experience; ideally in manufacturing, preferably GMP Setting
- Typically have 5 years related work experience in Aseptic manufacturing / process engineering.
- Equipment and process validation
- Sterile filling processes and equipment
- Lean Six Sigma Methodology experience desired.
If this role is of interest to you, please apply now!
#LI-CH3
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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