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Computer System Validation Engineer (CSV)

Co. Cork, Co. Cork
PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking an experienced Computer System Validation Engineer near Cork, Ireland.
Objectives of this Role:
  • Manage the Computer System Validation aspect of IT projects from software install to business release
  • Liaise with service providers and IT team to determine successful installation of software and ensure correct configuration
  • Responsibility for server installations and system related activities e.g. security, admin config settings, access permissions
  • Generate computer system validation documentation in accordance with site procedures and GMP guidelines
  • Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria
  • Work with the business to identify and implement procedural controls to mitigate issues found during testing
  • Initiate and implement Change Control activities in accordance with Quality Standards and Practices
  • Determine solutions or recommendations for changes and/or improvements
  • Prioritize validation activities in line with the project schedule
  • Following all relevant Environmental, Health and Safety procedures and assist in incident investigations as required
Skills and Qualifications:
  • Bachelor’s degree in Engineering or similar background, or prior industry experience
  • Minimum 5 years’ experience implementing IT solutions, systems integration, support & validating IT applications and interfaces
  • Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
  • Knowledge of 21CFR Part 11 requirements
  • Experience of Werum PAS X is required
  • Experience of server and workstation platforms
  • Strong oral and written communication skills are required, with ability to communicate and build relationships cross-functionally
  • Self-motivated, detail-oriented and excellent organizational and time management skills

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