Job Title: Software system validation engineer
Job Description:(Please Ignore if not good match)
• 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" and MS Access database
• 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