Software System Validation Engineer


Sarver, PA

Industry: Engineering Services


Less than 5 years

Posted 253 days ago

  by    Bajrang Yadav

This job is no longer available.

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


Primary Skills:

Computer system validation


Secondary Skills:


Educational Qualifications