What are the responsibilities and job description for the Computer system Validation Specialist position at Sunrise Systems, Inc.?
Job Title: CSV Specialist
Location: Portsmouth, NH, 03801
Duration: 06 Months
Summary
- The CSV Specialist Level 3 helps to lead team members to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. The CSV Specialist Level 3 will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. This position also provides guidance to junior team members.
Accountabilities:
- Specialist will be involved as the QA CSV representative during small and large-scale projects
- Perform all aspects of QMS process’ – Change Control, Deviations, CAPAs
- Execute all responsibilities as CSV project lead for simple projects
- Oversee/perform all CSV qualification activities for DeltaV and Syncade systems
- Perform Validation Maintenance of computerized systems
- Review/Revise CSV SOPs
- Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.)
- Assist with audits and inspections
- Perform other duties as assigned
Education:
- Bachelor’s Degree Required
- Field of Study : Computer Science / Software Engineering (Preferred)
- Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation
- Strong written and oral communication skills
- Strong organizational and time management skills
Salary : $70 - $73