Position: CSV Engineer. Location: Dublin, Ireland.
PACIV, a global leader in industrial automation solutions with offices in Ireland, the United States and Puerto Rico, and serving the Life Science, F&B and Utilities industries, is looking for an experienced CSV Engineer for our client in Dublin. This is a site-based hybrid role (3 days per week on site). Applicants must have a valid EU Work Permit and Irish Residency
Job Description
The Control System Validation (CSV) Engineer will be responsible for the development, review and execution of validation documentation and related tasks within a multinational pharmaceutical manufacturing environment.
Position Responsibilities/Essential Functions
* Support the automation system validation team (and wider automation team) on periodic review and improvement projects as requested.
* Development and execution of CSV strategies and documentation aligned with corporate and site standards.
* Preparation of design documentation protocols in conjunction with engineering and automation engineering personnel.
* Review and obtain approval for documents as per policies and procedures.
* Preparation and execution of Testing and Test documentation in conjunction with engineering and automation engineering personnel.
* Responsibility for ensuring accuracy and completeness of CSV documentation.
* Devising and developing templates and tools to facilitate overall validation and testing activities.
* Maintenance of CSV documentation.
* Preparation of periodic reviews.
* Work collaboratively with other functional groups to ensure alignment and resolve discrepancies.
* Take part in Supplier Assessments, Risk Assessments and Data Integrity Assessments.
Requirements
* Science or engineering degree.
* 3+ years' CSV experience.
* 5+ years' pharmaceutical manufacturing environment experience.
* Deep Knowledge of GMP, regulatory requirements and control system validation.
* Knowledge of automation systems including DeltaV DCS and PLC platforms.
* Excellent written and verbal communication skills for both technical and non-technical audiences.
* Strong teamwork skills.
* This is a site-based hybrid role (3 days per week on site).
* Please no agencies