Regulatory Compliance Engineer

6 days ago


Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

Job Description
Fujifilm Diosynth Biotechnologies is seeking a highly skilled Computer System Validation Engineer III to join our team. This role requires expertise in computerized systems validation, knowledge of regulatory requirements, and excellent communication skills.

Responsibilities and Qualifications

  • Validate Computer Systems
    • Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure.
    • Ensure documents meet regulatory and procedural requirements, including 21 CFR Part-11, Annex-11 Data Integrity, and GAMP5.
  • Lead Validation Activities
    • Plan and organize validation activities amongst cross-functional groups.
    • Provide status updates for validation activities related to day-to-day operations or project work.
  • Review SDLC Deliverables
    • Review all System Delivery Life Cycle (SDLC) deliverables.
    • Provide constructive feedback to ensure deliverables adhere to associated Standard Operating Procedures (SOPs).
    • Master's Degree with 2+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
    • Bachelor's Degree with 4+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
    • Associates Degree with 6+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.


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