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AI & Cloud Computer System Assurance (CSA) Engineer

Software-as-a-service provider transforming manufacturing operations in life science industries using advanced analytics and artificial intelligence.
Cloud
Mid-Level Software Engineer
Hybrid
101 - 500 Employees
2+ years of experience
AI · Healthcare · Enterprise SaaS

Description For AI & Cloud Computer System Assurance (CSA) Engineer

Aizon, a Series C-funded SaaS provider, is revolutionizing life science manufacturing through advanced analytics and AI. The AI & Cloud Computer System Assurance Engineer role is crucial for maintaining regulatory compliance across Aizon's platforms. Reporting to the CSO, this position oversees computer system validation, ensures GxP and 21 CFR Part 11 compliance, and supports customer and partner compliance activities. The role combines technical expertise with quality assurance, requiring knowledge of cloud applications (preferably AWS) and regulatory requirements. With 2+ years of experience needed, the position offers comprehensive benefits including equity, medical insurance, and professional development opportunities. Aizon's mission focuses on improving global health by optimizing medicine manufacturing, making this an opportunity to impact healthcare while working with cutting-edge technology. The company's diverse environment (27+ nationalities) and backing from major investors like NewVale Capital and Danaher make it an exciting place for career growth.

Last updated 8 days ago

Responsibilities For AI & Cloud Computer System Assurance (CSA) Engineer

  • Provide oversight for computer system validation from quality assurance perspective
  • Provide guidance on Computer System Assurance (CSA) validation issues
  • Support investigation of CSA defects and quality records
  • Review CSA validation activities and deliverables
  • Support external and internal audits
  • Establish and sustain computer system validation global policies
  • Partner with internal and external teams
  • Author and revise SOPs
  • Provide guidance on validation documents and protocols
  • Contribute to CSA improvements projects
  • Support compliance team on computerized system audits
  • Support customer and partner compliance activities
  • Support Marketing and Pre-Sales activities

Requirements For AI & Cloud Computer System Assurance (CSA) Engineer

  • Bachelor of Science in IT, Chemistry, Pharmacy, Biology, or related science/technical field
  • 2+ years experience in biopharmaceutical regulated industry
  • Knowledge of computer system assurance (CSA) requirements
  • Thorough knowledge of quality management and CSA (GMP, 21 CFR Part 11, Annex 11, Data Integrity, GAMP)
  • Knowledge of industry standards for computerized systems
  • Good knowledge of regulatory requirements (FDA, EMEA, ICH)
  • Knowledge of cloud applications, AWS is desirable
  • Experience in SaaS System Validation
  • Experience in international environments
  • Proficient in spoken and written English
  • Strong analytical and problem-solving skills
  • Excellent communication and negotiation skills
  • Technical skills based on cloud platforms

Benefits For AI & Cloud Computer System Assurance (CSA) Engineer

Equity
Medical Insurance
Dental Insurance
Education Budget
  • Competitive salary
  • Stock Options
  • Private Medical & Dental Insurance
  • Internal Training & Certifications
  • Professional development
  • Flexible schedule & Intensive Fridays
  • Flexible Remuneration Options
  • Language Training Courses
  • Top-notch tech pack (Mac)
  • Monthly Team Building Activities

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