**Job Title:** CSV Engineer
Location: Sligo, Ireland (Pharmaceutical Company)
We are seeking a highly skilled CSV Engineer to join our diverse team. As a CSV Engineer, you will be responsible for validating and maintaining computer systems, including process automation systems, information systems applications/infrastructure, and enterprise systems.
Key Responsibilities:
* Plan, implement, coordinate, and participate in a EU GMP compliant validation process for quality information technology and automation systems.
* Prepare and review validation documentation related to projects/change controls, including risk assessments, traceability matrices, and validation reports.
* Execute validation activities and protocols on affected systems.
* Manage computer system/automation related change controls and other compliance-related tasks.
* Lead and participate in the creation and review of existing and new CSV procedures and policies.
* Analyze the results of testing and determine the acceptability of results against predetermined criteria.
* Investigate and troubleshoot problems that occur and determine solutions or recommendations for changes and/or improvements.
* Identify current and anticipated requirements for compliant computerized operations and suggest methods for the identification, implementation, and maintenance of procedures, actions, and documentation necessary to ensure compliance with EU GMP Annex requirements.
* Audit internal projects against internal validation policies and procedures.
* Manage and coordinate the review and approval of specifications associated with Computerized Systems.
* Coordinate with internal Global Departments or outside contractors/vendors to complete validation tasks.
* Review and approve vendor validation documentation.
* Participate in regulatory audits and communicate the company's computer validation policies.
* Suggest Quality Approval of Vendors and Suppliers of GxP computer systems.
* Assess the company's computer systems and identify/address any potential 21CFR Part 11 or EU Annex 11 gaps.
* Manage projects and prepare status reports using Microsoft Project and other communication tools.
* Support local IT and Global IT on maintenance and testing of physical network infrastructure and security.
Requirements:
* Third-level degree in Science, Engineering, or Computer Science.
* 3+ years of related experience within the fields of Automation and Computer Systems and IT Infrastructure Qualification/validation.
* Experience with Enterprise Systems (ERP) in a GMP production environment is essential.
* Familiarity with EU GMP and Annex 11 Computerized System Validation requirements.
* Knowledge of GAMP5 guidelines.
* Excellent communication skills, including the ability to advise and influence.
* Proficient in Microsoft Office Suite, specifically Word, Excel, and PowerPoint.
Benefits:
* Competitive salary package.
* Bonus structure.
* Health Insurance.