CSV Engineer

3 weeks ago

Norwood, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • 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.
  • Collaborating with global IT and Quality teams
  • Following all relevant Environmental, Health and Safety procedures and assist in incident investigations as required
  • Should anticipate being on site at least 75% of the time with limited remote work.
  • Individual would be responsible for review / approval of vendor purchased computer system validation documentation.
  • Additionally, the individual would help with preparation of any CSV protocols where the service was not provided, as well as any "addendums" required. Field execution would be managed by other personnel.
Requirements:
  • 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, ER/ES and data integrity guidelines
  • Experience of OSI PI is an advantage.
  • Experience of data analytics and reporting solutions is an advantage.
  • Experience of server and workstation platforms and working in a Win 10 environment
  • Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
  • Self-motivated, detail-oriented, and excellent organizational and time management skills

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