CSV Engineer 1679
Posted 1 hour 48 minutes ago by SimoTech
Whatis it like to work at SimoTech? With a strong collaborative teamworkculture based on respect, trust, and excellence, we play a criticalpartnering role to our clients' life-changing supply of products topatients. In return, there is excellent salary, benefits, careerprogression, educational support andmuch more.
SimoTech are seeking a Labs CSV Engineer to support a pharmaceutical client based in Co. Louth. Working under the direction of the site Process Equipment Validation (PEV) team, the successful candidate will provide hands on validation and technical support for laboratory equipment and Lab IT systems across the project lifecycle.
The role will focus on delivering risk based validation activities, including Data Integrity / ERES assessments, review of vendor validation documentation, and support of deviations, impact assessments, and change control activities.
The ideal candidate will have a minimum of 5 years' experience within the pharmaceutical industry, delivering compliant CSV support for laboratory or manufacturing systems in line with regulatory and data integrity requirements.
Key Responsibilities- Work under the direction of the site Engineering team, providing hands on validation and technical support for manufacturing benchtop equipment.
- Support the rollout of networking functionality to arrange of benchtop instruments across a variety of instrument families.
- Lead and execute risk assessments prior to test execution, including Data Integrity / ERES assessments and functional risk assessments, applying sound judgment appropriate to system criticality.
- Review, assess, and leverage vendor validation documentation, including protocols, test evidence, and validation summary reports, to support a risk based validation approach.
- Participate in and support deviation investigations, impact assessments, root cause analysis, and change control activities, providing technical input and recommendations.
- Contribute to and, where appropriate, take ownership of project deliverables, including design documentation, configuration/build, installation support, and validation execution (IQ/OQ/PQ or equivalent).
- Act as a key technical interface with vendors, IT, QA, and manufacturing stakeholders, ensuring alignment with site standards and project expectations.
- Provide clear, timely communication to project leadership and stakeholders on status, risks, and issues.
- Ensure all activities are performed in compliance with applicable regulatory and internal requirements, including cGLP/cGMP, EHS, Global Engineering standards, design and construction directives, and relevant local and federal regulations.
- Bachelor or Master's Degree in Engineering, Life Sciences, Computer Science.
- At least five years' CSV experience, including a minimum of two years supporting systems in a labs or manufacturing environment.
- Experience of the validation of the following instruments: Filter Integrity testers, Vi-Cell, Solo VPE etc.
- Experience with the networking of IT equipment would be an advantage.
- Significant knowledge of regulatory requirements relating to CSV and Data Integrity including 21 CFR Part 11 / EU Annex 11.
- Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
- Develop new skills and enhance technical ability by working with innovative technologies in a multi disciplinary environment.
- Opportunity to work with large corporate clients.