Project specification
Project expertise
Description
An organization is looking for an experienced Commissioning & Qualification (C&Q) Engineer to qualify and start up production equipment in accordance with GMP standards. The aim of the project is to ensure the technical and organizational prerequisites for the GMP-compliant qualification of the production equipment.
Independently carrying out commissioning and qualification activities, especially in IOQ
Operating PCS7 systems
Working with single-use equipment
Performing commissioning and qualification activities for production equipment
Ensuring all technical and organizational requirements for C&Q
GMP-compliant qualification of the related production equipment
Requirements
- At least 3 years of experience in qualification (especially IOQ)
- Experience in carrying out commissioning and qualification
- Knowledge of PCS7 systems (independent operation without support)
- Experience with single-use equipment
- Bachelor’s or Master’s degree in engineering or natural sciences
- Specialization in process or automation engineering
- GMP training
- CSV knowledge (Computer System Validation)
- Regulatory compliance (EU GMP Annex 15, FDA guidance)
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