Computer Systems Validation Specialist, Level 3
About The Position
The Computer Systems Validation (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 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 get A collaborative and inclusive work environment. Opportunities for career growth and development. Access to cutting-edge technologies and tools. Competitive compensation and benefits package. Supportive leadership and mentoring. Commitment to ethical and sustainable practices.
Requirements
- Bachelor's degree in computer science, engineering, or related field.
- At least 5+ years of experience in automation or system validation.
- 2+ 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.
Nice To Haves
- DeltaV is preferred.
Responsibilities
- 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.
Benefits
- A collaborative and inclusive work environment.
- Opportunities for career growth and development.
- Access to cutting-edge technologies and tools.
- Competitive compensation and benefits package.
- Supportive leadership and mentoring.
- Commitment to ethical and sustainable practices.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Professional, Scientific, and Technical Services
Number of Employees
5,001-10,000 employees
