Computer System Validation Engineer

7 days ago

Singapore beBeeComputer Full time $90,000 - $120,000

Validation Specialist Job Description

This role involves ensuring the quality of computerized systems, particularly in areas related to Good Manufacturing Practices (GMP). The ideal candidate will have strong analytical skills and experience working with cross-functional teams.

Responsibilities:
  • Provide Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures.
  • As the Subject Matter Expert (SME) in CSV topics, provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV Plan and 21CFR Part 11.
  • Act as one of the key focal points for CSV topics such as deviations, change management, investigations, CAPA identification and closure and as a Subject Matter Expert.
  • Generate, review and execute protocols/test cases for initial validation programs related to GXP Computer systems.
  • Review and approve qualification documentations like URS, SLIA (system level impact assessment)/ CLIA (component level impact assessment), SRA (System Risk Assessment), DIRA/ DSA (Data security, audit trail review), DQ, SIOQ, HIOQ, FAT, FATSR, Traceability Matrix etc.
  • Ensure adherence to CSV master plans and execution plans for GXP computer systems like DCS, PLC, BMS, MES, eBR, Lab Information systems, Environmental monitoring systems and other Business IT systems like Maximo, Network and ERP systems that are part of the GMP envelope in a Biologics manufacturing facility.
Requirements:
  • Minimum bachelor's degree or higher in Science or Engineering or equivalent with at least 3 years of relevant work experience.
  • Minimum 1 year 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.
  • Shows 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.
Benefits:
  • MES
  • DCS
  • CAPA
  • Risk Assessment
  • Hardware
  • Change Management
  • ERP
  • GMP
  • Information Technology
  • Traceability
  • PLC
  • FOCAL
  • Good Communication Skills
  • Regulatory Requirements
  • Manufacturing
  • Commissioning
Others:
  • Tell employers what skills you have
    MES
    DCS
    CAPA
    Risk Assessment
    Hardware
    Change Management
    ERP
    GMP
    Information Technology
    Traceability
    PLC
    FOCAL
    Good Communication Skills
    Regulatory Requirements
    Manufacturing
    Commissioning

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