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Computer Systems Validation Specialist III

Date Posted: Jun 23, 2026
Yearly: USD - USD

Job Detail

  • location_on
    Location Portsmouth, New Hampshire, United States of America
  • desktop_windows
    Job Type: Permanent
  • schedule
    Shift:
  • analytics
    Career Level:
  • group
    Positions:
  • calendar_view_day
    Experience:
  • male
    Gender: No Preference
  • school
    Degree:
  • calendar_month
    Apply Before: Sep 21, 2026

Job Description

Overview

The Computer Systems Validation Specialist III at Lonza will lead teams in assessing new and changing computer systems to ensure compliance with company policies and industry guidance. This role involves conducting risk assessments, drafting protocols, and providing mentorship to junior team members while overseeing GMP documentation revisions.

Key responsibilities

  • Conduct risk assessments and review change requests
  • Draft protocols and oversee GMP documentation revisions
  • Act as the QA CSV representative for small and large-scale projects
  • Perform all aspects of QMS processes - Change Control, Deviations, CAPAs
  • Perform gap assessments to identify process gaps and suggest remediation plans
  • Author, review, and approve end-to-end computer system validation lifecycle deliverables
  • Schedule qualification activities and personnel to meet business objectives
  • Revise and maintain SOPs to ensure compliance
  • Support validation requests as a CSV SME during customer audits and inspections

Required skills

  • Bachelor's degree in computer science, engineering, or related field
  • 3+ years of experience in computer systems validation
  • 3+ years of experience in a cGMP facility
  • Knowledge of 21 CFR Part 11 and ISPE GAMP guidelines
  • Experience in biotech, pharma, or medical device industry
  • Ability to work independently and in teams

What the company offers

  • Collaborative and inclusive work environment
  • Opportunities for career growth and development
  • Access to cutting-edge technologies and tools
  • Competitive compensation and benefits package
  • 401(k) matching plan
  • Supportive leadership and mentoring
  • Commitment to ethical and sustainable practices

Skills Required

Company Overview

Portsmouth, New Hampshire, United States of America

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passio... Read More

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