Quality Assurance Analyst III - Asset Engineer

Added
16 hours ago
Type
Full time
Salary
Salary not provided

Related skills

data integrity asset management equipment 21 cfr part 11 change control

📋 Description

  • Manages equipment-related requests and small projects via change control.
  • Support and execute operational C&Q activities aligned with Global processes.
  • Serve as Asset SME for CAR-T equipment.
  • Contribute to asset technical requirements and standards.
  • Provide guidance on compliance and data integrity requirements.
  • Identify gaps between Global and local compliance; drive CAR-T technical consistency.
  • Develop and maintain strong strategic vendor relationships.
  • Sustain continuous technical improvements across the asset base.
  • Coordinate with internal teams and suppliers to drive solutions.
  • Support investigations during C&Q activities and operations.
  • Drive evaluation and business case for new asset technologies.

🎯 Requirements

  • Master’s Degree in Science, Engineering, or related field required.
  • 3+ years in pharmaceutical manufacturing or engineering.
  • Experience with commissioning & qualification (C&Q).
  • Knowledge of data integrity and 21 CFR Part 11.
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