Engineering Validation

2 weeks ago


Singapore Amaris Consulting Full time

About the job

  • Serve as a site Subject Matter Expert for at least 1 specialized validation area
  • Planning, performance, support and coordination of Computer System Validation, Equipment validation, Sterilization In Place, cleanroom validation, Clean Utilities Validation (IQ/OQ/PQ/CPV)
  • Maintain validation status of Computer System Validation
  • Independently scheduling, organization and coordination of detailed site level validation activities with cross functional groups.
  • Support data evaluation if necessary
  • Ongoing feedback of validation status to responsible user
  • Creation of SOPs or documentation related to the validation activities or maintenance
  • Review and check documentation for GMP compliance
  • Project support for system/equipment where validation is impacted
  • Definition of relevant equipment investment projects and in creation of User Requirement specifications if required.
  • Participate in audits
  • Presentation of explanation of validation approach, projects and results

About you

  • Bachelor's Degree or higher in biological/pharmaceutical sciences or engineering sciences. Equivalent degree or experience possible
  • At least 4 years of working experience in Pharmaceutical/ GMP
  • Specialized knowledge of relevant GMP guidelines
  • Time management and organizational skills for specific projects
  • Able to execute activities in cGMP environment, including cleanrooms or technical areas
  • Enthusiastic and selfdriven
  • Team player but able to work on own initiative
  • Good communicator who enjoys working in a dynamic and multicultural environment

Equal opportunity

Job Types:
Full-time, Permanent

Schedule:

  • Monday to Friday

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