Computer System Validation Engineer
This is a permanent role that presents an exciting opportunity to make a real impact and be part of our company's journey. If you are looking to join a team where your skills can truly make a difference, this could be the perfect fit.
We are seeking candidates with circa 3 years experience in Computer System Validation (CSV) who possess the following skills:
* Managing CSV automation change controls and non-conformances.
* Participating in reviews of CSV procedures and protocols.
* Ensuring compliance for CSV.
* Demonstrated experience with Annex 11.
* Experience with ERP in a GMP manufacturing environment.
Day-to-Day Responsibilities:
* Prepares and reviews validation documentation related to projects and change controls, including risk assessments, traceability matrices, and validation reports.
* Executes validation activities and protocols on affected systems.
* Manages computer system/automation related change controls and other compliance-related tasks.
* Participates in the creation and review of existing and new CSV procedures and policies.
* Analyses the results of testing and determines the acceptability of results against predetermined criteria.
* Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
* Auditing of internal projects against internal validation policies and procedures.
* Managing and coordinating the review and approval of specifications associated with Computerised Systems.
* Coordinates with internal Global Departments or outside contractors/vendors to complete validation tasks.
* Reviews and approves vendor validation documentation.
* Participates in regulatory audits and communicates the company's computer validation policies.
* Supports the Quality Approval of Vendors and Suppliers of GxP computer systems.
* Assesses the company's computer systems and identifies/addresses any potential 21CFR Part 11 or EU Annex 11 gaps.
* Manages projects and prepares status reports using Microsoft Project and other communication tools.
* Supports local IT and Global IT on maintenance and testing of physical network infrastructure and security.
Qualifications, Experience and Skills:
* A third-level degree in Science, Engineering, or Computer Science.
* Minimum 3+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation.
This role requires a strong understanding of CSV principles and practices, as well as excellent analytical and problem-solving skills. If you have a passion for technology and a drive to succeed, we encourage you to apply.