System Validation Engineer

5 days ago

Singapore beBeeValidation Full time

Job Title: CSV Validation Specialist

We are seeking a skilled CSV Validation Specialist to join our team. The ideal candidate will have a strong understanding of computerized system validation (CSV) principles and regulations, as well as experience working with cross-functional teams to ensure quality oversight in the life cycle procedure.

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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