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Process Engineer - I - FSR Level - P1
- This is 11 months contract. The Process Engineer is a high profile role within the operations department at MSD Carlow with excellent career progression potential.
- The Process Engineer will be responsible for authoring and managing the review and approval processes for IPT deliverables such as Quality Notifications, CAPA close out records and change controls.
- As competency in the area increases the IPT production coordinator will take on additional responsibility for identifying and leading process improvement / lean initiatives within the IPT and support new product development / Technology Transfer.
- Support manufacturing activities through drafting technical reports, equipment and process investigations and completion of quality notifications.
- Author, review and approve necessary operations and technical documentation in line with the standard approval process.
- Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
- Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
- Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.
- Identify, investigate and remedy process issues and incidents, using Lean Six Sigma tools as applicable. Lead cross functional root cause analysis investigations for process improvement initiatives and complete improvement projects for IPT. Participate, and lead, on-site Kaizen activities and drive the culture of continuous incremental improvement on site.
- Required to comply with Merck Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
- Support new product development and technology transfer activities in an operations process engineer capacity.
- May be required to perform other duties as assigned.