Crest Solutions are excited to welcome applications for a Process Validation Engineer role based on our customer site in Cork.
The Process Validation Engineer will provide automation validation support for systems in operating areas across site and/or for capital projects.
Role Responsibilities
- Development and execution of validation strategies
- Development and execution of validation documentation
- Preparation of Computer System Validation documentation aligned with corporate and site standards
- Preparation of design documentation protocols in conjunction with engineering and automation engineering personnel
- Preparation and execution of Testing and Test documentation in conjunction with engineering and automation engineering personnel
- Responsibility for ensuring accuracy and completeness of Computer System validation documentation
- Devising and developing templates and tools to facilitate overall validation and testing activities
- Maintenance of Computer System Validation Documentation
- Preparation of Periodic reviews, Audit Trail reviews, Data Integrity Assessments.
- Management of automation projects
- Degree in Chemical Engineering, Applied Physics and Instrumentation, Electrical or Electronic Engineering or qualifications in other relevant engineering discipline with appropriate experience
- Minimum 2 years’ experience in the Pharmaceutical Industry
- Understanding of Distributed Control Systems
- Understanding of IT platforms such as networks and servers
- Knowledge of GMP’s, regulatory requirements , computer system validation
- Very good written and verbal communication skills for both technical and non-technical audiences
