Title: Senior Process Engineer
Summary: Our Client, a Waterford based pharmaceutical company, are seeking an experienced Process Engineer to join their team to manage process equipment introductions and qualifications, validations, organising operations and maintenance support and raw materials for both engineering and process optimisation batches.
- Lead and coordinate process equipment projects.
- Identify and lead process improvements and projects
- Oversee various manufacturing and packaging PV executions which includes organising, writing documents and execution.
- Make sure qualification methodology is clear and merged into projects.
- Always ensure the documentation, training and handover meet internal customers' requirements.
- Plan and carry out process validation schedules for both the manufacturing and packaging processes.
- Report on schedule, cost control, project scope and risks when appropriate.
- Liaise and upkeep effective communication with contractors/customers and multiple company departments to manage resources, materials, and equipment and make sure validation processes are completed in line with appropriate deadlines.
- Review and revise validation documents such as SOP's, protocols etc.
- Investigate and conclude issues in validation processes and extend technical support for process and equipment issues which may arise.
- Generate and analyse statistical data to verify acceptable criteria has been upheld and met.
- Make sure contractors are budgeted, approved, scheduled, qualified, and permitted for the tasks they undertake.
- Upkeep effective communication with both internal and external stakeholders.
Qualifications and Experience:
- 3-6 years' Pharma engineering experience is highly desirable.
- Experience in manufacturing and/or packaging.
- Excellent communication, organisation, and problem-solving skills.
- Knowledge and experience of validation, project management, audits, reporting, troubleshooting, equipment qualification.
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