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.?
- Experience Level (Years) 3-6year
- 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
- Computer system validation