Headcount Solutions is sourcing a Process Engineer for a client’s biotech facility. This person will be responsible for generating and expediting review and approval processes for GMP documentation including but not limited to Quality Notifications, CAPA close out records, Standard Operating Procedures and Standard Work Instructions and change controls.
*This a shift-based role supporting 24/7 manufacturing operations.
- 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.
- Be a document system expert; this will include document review, approval and document system workflow 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.
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other technical discipline.
- SAP knowledge and experience is advantageous.
- Proficiency in Microsoft Office and job-related computer applications required.
- Report, standards, policy writing skills required.
- Equipment and process validation experience is highly desirable.
- Lean Six Sigma Methodology experience desired.
For further information please contact Michael on 086-0435195 or forward details in confidence to [email protected]