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Full-time Need Validation Engineer

at Agelix Consulting Inc. in Pennsylvania

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
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
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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Published at 29-05-2018
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