Job Title: Software system validation engineer
? 3+ years' experience as Computer System Validation writing Computer System Validation test scripts is REQUIRED.
?Experience in Computer Systems Validation environment with at least 2 years performing in the IT Quality and Compliance and/or data integrity roles.
? Knowledgeable in Computer System Validation with experience in GAMP5 Category 5 ?Custom Built System?.
?Experience with GxP validated, 21 CFR Part 11 compliant computer systems is a MUST.
? Knowledgeable in Spreadsheet qualification including but not limited to Installation, Operational and Performance Qualifications. Knowledgeable in generation of User, System and Design requirements. Able to author CSV completion reports.
? Sufficiently knowledgeable of FDA Regulatory Requirements and industry best practices for computerized system validation to complete tasks.
? MUST have Pharmaceutical, Bio-Technology, or Life Science industry experience
? Excellent client-facing and internal communication skills
? Excellent written and verbal communication skills
? Solid organizational skills including attention to detail and multi-tasking skills
? Medical device industry experience
? Understanding of medical device (21CFR 820 & ISO13485) regulatory standards and engineering applications
Computer system validation