CSV Engineer

Job content

• Plans and coordinates computer software validation projects and activities
• Provides regulatory compliance, guidance and support on CSV activities
• Creates, reviews and approves system validation deliverables, for example: validation plan
• Participates in projects on setting up quality management system and quality risk management
• Create and modify validation documentation including but not limited to:

- Criticality assessments
- CSV protocols (SAT, IQ, OQ) which verify if the system is compliant to regulatory and client -requirements.
- Reports which summarize the results of the protocol executions.
- Exception reports which identify defects or issues during test execution.
- Support in the review and interpretation of data for accuracy in completed validations
- Contribute to status reporting

• Review executed protocols and generated reports in accordance with GMP and document quality requirements
• Assist in troubleshooting of issues identified by test performers during protocol execution.

• Degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, chemical engineering, engineering or a related discipline
• Experience in computer system validation in qualifying Electronic Batch Management systems
• Experience to Reviews, Approve computer system validation lifecycle documentations, e.g. IQ, OQ, PQ protocols and reports
• Hands on experience with in performing equipment validation
• Excellent communication skills (verbal and writing)

Equal opportunity

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics.