Need Validation Engineer

  • Free
  • Published date: May 29, 2018
    • Pennsylvania, United States

Validation Engineer

Sarver, PA



Job Description



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


Reference : Need Validation Engineer jobs

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