Computer Systems Validation (CSV) Engineer
PSC Biotech
2 months ago

Computer Systems Validation (CSV) Engineer - 1858 Responsibilities :

Working Location : Singapore

  • Working as part of a multi-disciplinary validation team responsible for validation of automated equipment, distributed control systems and computerised controls in new and modified pharmaceutical and life science facilities
  • Coordinating and performing testing activities
  • Developing various test specifications which includes functional testing, system integration testing, performance testing and compliance testing
  • Continuously improving quality of test processes
  • Working on application software testing to assist project teams in delivering quality system
  • Writing Validation Protocols such as IQ, OQ and PQs
  • Executing Validation Protocols such as IQ, OQ and PQs
  • Calibrating Thermocouples for Temperature Mapping Studies
  • Calculating and interpreting of collected data from validation studies
  • Generating Validation Summary Reports and Standard Operating Procedures (SOPs)
  • Conducting Risk Assessments
  • Completing work assignments as specified by the Validation Project Manager
  • Providing timely updates to the Validation Project Manager
  • Working in a biotech / pharmaceutical environment as a Validation consultant / contractor for various clients of PSC
  • Adhering to the proper site safety practices; wearing adequate safety equipment when required
  • Completing timesheets and expense reports in a timely manner
  • Mentoring junior staff and interns
  • Requirements :

  • Bachelor's Degree in Electrical Engineering, Computer Science / Information Technology, Chemical / Biochemical / Mechanical Engineering preferred
  • Knowledgeable in medical device and pharmaceutical CSV requirements
  • Minimum 2 years of experience in support and installation of MES or Distributed control systems or in commissioning and / or validation automated equipment and systems, preferably with experience in one or all of the followings : Siemens PCS 7, SAP and Werum MES
  • Experience in IT infrastructure and applicable validation requirements. (Server and Communication system) eg. BMS / SCADA / MES system
  • Incumbent with more years of relevant experience and project management exposure, may be considered for senior roles.
  • Experienced candidates with in depth knowledge of the above systems, but with limited validation experience may be considered
  • Knowledgeable in 21 CFR PART 11 requirements
  • Knowledge of validation test instruments such as Kaye Validator is an advantage
  • A team player who is able to work under pressure and flexible with aggressive project timeline
  • High energy and attention to details
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