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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