Computer Systems Validation Professional

6 days ago

Singapore beBeeValidation Full time $80,000 - $120,000
Job Title: CSV Validation Specialist

We are seeking a skilled professional to join our team as a CSV Validation Specialist. The ideal candidate will have a strong understanding of computerized system validation (CSV) principles and regulations.

The successful candidate will provide guidance and support to ensure data integrity and compliance to CSV plans and 21CFR Part 11. They will also act as a Subject Matter Expert (SME) in CSV topics, including deviations, change management, investigations, CAPA identification and closure.

Responsibilities include generating, reviewing and executing protocols/test cases for initial validation programs related to GXP Computer systems. The candidate will also review and approve qualification documentations, such as URS, SLIA/CLIA, SRA, DIRA/DSA, DQ, SIOQ, HIOQ, FAT, FATSR and Traceability Matrix.

Key Responsibilities:

  • Provide guidance and support to establish systems for ensuring data integrity and compliance to CSV plans and 21CFR Part 11.
  • Act as a Subject Matter Expert (SME) in CSV topics, including deviations, change management, investigations, CAPA identification and closure.
  • Generate, review and execute protocols/test cases for initial validation programs related to GXP Computer systems.
  • Review and approve qualification documentations, such as URS, SLIA/CLIA, SRA, DIRA/DSA, DQ, SIOQ, HIOQ, FAT, FATSR and Traceability Matrix.
  • Ensure adherence to CSV master plans and execution plans for GXP computer systems, including DCS, PLC, BMS, MES, eBR, Lab Information systems and other Business IT systems.

Requirements:

  • Bachelor's degree or higher in Science or Engineering or equivalent with at least 3 years of relevant work experience.
  • At least 1 year of experience with Emerson DeltaV system – software coding review.
  • Working experience and knowledge on CSV of start-ups and brownfield project experience in both Operation Technology / Information Technology system is a plus.
  • Hands-on experience in Validation life cycle of computer systems is a must.
  • Experience in Siemens PLC system is a plus.
  • Good communication skills.
  • Excellent team player willing to work for the common goal.
  • Knowledge of pharmaceutical regulatory requirements (GMP) is essential.
  • Show a high level of tenacity to ensure closure of issues.
  • Largely self-managed with ability to communicate upwards and cross functionally to ensure all key project milestones are met.

What We Offer:

  • A dynamic and supportive work environment.
  • The opportunity to work with a talented team of professionals.
  • A competitive salary and benefits package.

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