Validation Engineer
Kashiv Biosciences LLCNew Jersey, United States
Posted June 19, 2025
Full Time
About the Company
Kashiv Biosciences LLC specializes in biosimilar manufacturing and process equipment support, offering HVAC and BMS maintenance, equipment validation, and intellectual property services for downstream cell culture processes. The company operates in a GMP-compliant environment, providing technical expertise in bioreactor, fermenter, and downstream process equipment maintenance and IP strategy development.
Job Description
The Validation Engineer will be responsible for establishing and maintaining good validation practices within the organization. This role involves drafting documentation, executing validation procedures, coordinating with vendors and users, and providing support to non-engineering teams. The role requires strong communication and technical writing skills.
Requirements
- Draft and implement Quality System documentation including SOPs and Traceability Matrix
- Author URS, IQ, OQ, and PQ protocols
- Coordinate all validation activities with vendors and analyze results
- Provide input on user/functional requirements
- Interface with Contract Manufacturers
- Provide support to non-engineering Staff
- Execute assigned duties on time and proactively
- Comply with regulatory policies