Process Engineer (III)
This role will lead technical manufacturing investigations managing cross functional support from key departments and Global Manufacturing Division where required, lead manufacturing quality risk assessments per QRM process, act as Manufacturing Technical SME within the IPT PSS Group. 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
- Lead technical manufacturing investigations, managing cross functional support from key departments and Global Manufacturing Division as required.
- Lead Manufacturing Quality Risk Assessments as per QRM process.
- Technical SME in Manufacturing Processes, responsible for writing manufacturing technical reports and investigations
- Manufacturing Systems SME ( i.e. SAP , MES , Delta V , Pi Historian)
- Lead Customer Complaint investigations co-ordinating and liaising with downstream sites as required.
- 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 Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.
Skills and Knowledge:
- Typical Minimum Education:
Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
- Typical Minimum Experience:
10+ years (GMP) manufacturing experience required.
Significant Technical experience in manufacturing processes required.
Advanced technical report and investigation writing experience required.
o Advanced Technically report writing skill required
o Ability to lead Manufacturing Quality Risk Assessments
o Advance SAP knowledge and experience required
o Advanced proficiency in Microsoft Office and job related computer applications required
o Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
o Equipment and process validation
o Sterile filling processes and equipment
o Lean Six Sigma Methodology experience desired
o Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
o Understand the specific responsibilities of all departments as they relate to one's own department, understanding the business processes ones department supports
o Strong team skills, including ability to coach/develop work teams
o Excellent training, facilitation and assessment skills
o Risk management skills
o Focus on Customers and Patients
o Make Rapid, Disciplined Decisions
o Drive Results
o Build Talent
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