Computer Systems Validation (CSV) SpecialistLocation: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families.
The Computer Systems Validation (CSV) Specialist 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 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 and will be involved as the QA CSV representative during small and large-scale projects.
What you will do:- 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.
What we are looking for:- Bachelor's degree in computer science, engineering, or related field.
- 3+ years experience in Computer Systems Validation and in a cGMP facility.
- 1+ years with Programmable Logic Controllers (PLC), Controls Automation, Process Control Systems, SCADA Systems, Distributed Controls Systems (DCS), Building Alarm Systems (BAS), Building Management Systems (BMS), Manufacturing Execution Systems (MES) required, DeltaV is preferred.
- Experience leading projects and managing CAPAs and deviations.
- Background in biotech, pharma, or medical device industry.
- Strong attention to detail and ability to meet deadlines.
- Ability to work independently and on-site in Portsmouth NH.
