Software System Validation Engineer

  •  

Sarver, PA

Industry: IT Consulting/Services

  •  

Less than 5 years

Posted 277 days ago

This job is no longer available.

We are looking for Software System Validation Engineer for our client in Sarver, PA

Job Title: Software System Validation Engineer

Job Location: Sarver, PA

Job Type: Contract ? 12 Months / Contract to Hire / Direct Hire

?US citizens and those authorized to work in the US are encouraged to apply. We are unable to sponsor H1b candidates at this time.? 

Job Description:

  • Experience Level (Years) 3-6year 

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 2years 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 application

Primary Skills:

  • Computer system validation

Educational Qualifications

  • Engineering