Software System Validation Engineer

Larsen & Toubro  •  Sarver, PA

Less than 5 years experience  •  Engineering Services

Salary depends on experience
Posted on 03/09/18 by Bajrang Yadav
Larsen & Toubro
Sarver, PA
Less than 5 years experience
Engineering Services
Salary depends on experience
Posted on 03/09/18 Bajrang Yadav

Job Title: Software system validation engineer

 

Overview:

? 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

Engineering 

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