Senior Validation Engineer (CSV), Biotechnology - (JP15063)
About The Position
3 Key Consulting is hiring a Senior Validation Engineer (CSV), Biotechnology for a consulting engagement with our direct client, a leading global biopharmaceutical company. Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues. Additional responsibilities will include support in development of audit readiness materials and gmp documentation generation and review. This is an on site position. Why is the Position Open? Supplement additional workload on team
Requirements
- Inspection Shut down Validation
- Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience
Responsibilities
- Ensuring adherence to computer validation standards and procedures for computer related systems
- Participation in system design
- Preparation of test protocols
- Analysis of test results
- Preparation of summaries
- Producing quality documentation
- Serves as the liaison between the IS and Quality functions
- Provides testing and IT compliance guidance
- Provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues
- Support in development of audit readiness materials and gmp documentation generation and review
- General validation and commissioning support
- Generation and management of documents
- Support of audit readiness
- Other engineering support tasks
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What This Job Offers
Career Level
Senior
Education Level
High school or GED
