In partnership with our client in the chemical manufacturing arena, we are currently looking to identify a CSV Specialist to provide support for data integrity improvement in Bethlehem, PA.
This is a 6 month contract position and on-site only.
The CSV specialist will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs.
Responsibilities include the following:
Designs, modifies, develops, writes, reviews and implements all Computer System Validation (CSV) documents, protocols and reports for validation and qualification work. Validates and coordinates all validation activities (Commissioning, Qualification, and Validation) by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Generate Standard Operating Procedures (SOP) for computerized and manufacturing systems. Generate changes reports or documents for new or modified equipment
At least 5 years of Computer System Validation required including experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report). Experience with Waters NuGenesis system and understanding of data integrity requirements a plus.