Validation Engineer 2

CSV Specialist

Location: Portsmouth, NH, 03801 Duration: 06 Months

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