Commissioning & Qualification Process Engineer
Eastgate Engineering is seeking to recruit a Process Engineer with 5-10 years C&Q experience for a Dublin, Ireland, based Pharmaceutical project.
Work within the project commissioning and qualification team as the hands on process engineer for the project, ensuring compliance with all applicable regulatory and internal Quality standards and industry best practice by conducting and/or witnessing C&Q activities and documenting
results. Implements corrective actions to achieve compliance to standards and performance requirements
Position roles & responsibilities:
- Maintain list of process C&Q tests (Installation Verification (IV), Operational Verification (OV), Operational Qualification (OQ), Performance Testing (PT) and Performance Qualification (PQ)
- Review, develop and take ownership of the required processes relating to commissioning and qualification, ensuring compliance with all applicable regulatory, functional and internal Quality standards and industry best practice with zero impact to the process development, facilities or operations functions.
- Execution of process commissioning & qualification tests in adherence with project schedule and under the direction of the C&Q manager. Populate project specific documentation for C&Q activities
- Work with the construction QA/QC team to accepts turnover of equipment / system from construction group.
- Support service or equipment vendors when undertaking qualification as required to ensure that applicable standards are adhered to.
- Integrate with and interact across all relevant functions including Maintenance, Facilities, Quality Assurance, Production and Supply Chain to ensure compliant C&Q delivery to the assets across the site.
The project Process C&Q engineer reports to the Project C&Q Manager.
Significant experience working within a project C&Q team as a Process engineer in the chemical/pharmaceutical industry essential including bio-pharmaceutical and documentation requirements.
3 – 5 years in similar role preferred
- Degree level qualification, science, process or mechanical engineering discipline preferred.