Software System Validation Engineer

  •  

Sarver, PA

Industry: Technology

  •  

Less than 5 years

Posted 27 days ago

  by    Bajrang Yadav

Job Title: Software system validation engineer

Location: Sarver,PA

Job Description:(Please Ignore if not good match)

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" 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

Primary Skills:

Computer system validation

Secondary Skills:

Educational Qualifications

Engineering