PE Global is currently recruiting for a Process Engineer for a leading multi-national Biotech client based in Carlow.
This is an initial 11-month contract position working on a 24/7 Shift.
ROLE:
- 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.
- 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 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.
- May be required to perform other duties as assigned.
- Assist in the management and/or assignment of training if required
REQUIREMENTS:
- Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
- SAP knowledge and experience required
- Proficiency in Microsoft Office and job-related computer applications required
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Report, standards, policy writing skills required
- Equipment and process validation
- Sterile filling processes and equipment
- Lean Six Sigma Methodology experience desired
Interested candidates should submit an updated CV.
Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up to date CV to sean.molloy@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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