Process Engineer - P2 PSS
The Highlights:
- Joining a well - established team
- Working with clinical and commercial products
- Great Workculture and Approachable management
The Role:
Elusav Recruitment have an excellent opportunity with a leading global biopharma company who is seeking a Process Engineer for Fill finish and automated inspections area due to a recent expansion of the facilities production capacities.
The Process engineer will provide provide day to day Process Engineering support to existing syringe inspection area. Responsible for generating and expediting review and approval processes for IPT GMP documentation including but not limited to Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls.
Job Responsibilities:
- Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.
- Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT.
- Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so.
- Documents will include SOP’s, SWI’s, training documents, and change controls.
- Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.
- 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.
- 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.
- Work collaboratively to drive a safe and compliant culture in Carlow.
- May be required to perform other duties as assigned.
- Assist in the management and/or assignment of IPT training if require.
Job Requirements:
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
- Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting.
If you would like to learn more about the vacancy, apply now, or contact Stephen O'Brien on stephen@elusav.com or +3536959993.
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