Posted 2 months ago
We are looking for experienced CSV (Computer Systems Validation) and CQV (Commissioning, Qualification, and Validation) consultants to support BioPharma projects in Europe. This role focuses on validation and qualification of systems, equipment, and processes, ensuring compliance with industry regulations.
Key Responsibilities
- CSV Activities:
- Write, execute, and review validation documents using platforms like TIMS (priority), Kneat, and eVal.
- Develop validation strategies (OV, RTM, DER-O) and support system testing and compliance.
- CQV Activities:
- Perform commissioning and qualification for equipment, utilities, and facilities.
- Focus on process and cleaning validation within GMP-regulated environments.
- Testing Expertise:
- Test automation systems such as ABB (priority) and Delta V, ensuring functionality and compliance.
Required Qualifications
- Experience:
- Strong background in CSV and CQV for BioPharma or Pharma projects.
- Hands-on experience with TIMS (priority), Kneat, and eVal platforms.
- Testing experience with ABB and Delta V systems.
- Skills:
- Expertise in greenfield/expansion projects and validation processes.
- Strong understanding of GMP and regulatory standards.
- Excellent communication and team collaboration skills.