Lonza
Life Sciences
ComputerSystemsValidationSpecialistIII
Neural analysis suggests this role is
optimal for Mid candidates.
“Computer Systems Validation Specialist III at Lonza. Skills: Computer Systems Validation, cGMP facility, 21 CFR Part 11, ISPE GAMP. Assess new and changing computer systems. Conduct risk assessments”
What You'll Achieve.
Ensure compliance with company policies; Ensure compliance with industry guidance; Meet business, manufacturing, engineering and quality objectives; Ensure continuous improvement and compliance
Industry & Context.
Suggest remediation plans
Ability to work on-site in Portsmouth NH
What They're Looking For.
Must Have
Bachelor’s degree in computer science, engineering, or related field, 3+ years of experience in computer systems validation, 3+ years of Experience in working in a cGMP facility, Experience with 21 CFR Part 11, Experience with ISPE GAMP guidelines, Ability to work independently and on-site in Portsmouth NH
Nice to Have
Background in biotech, pharma, or medical device industry
What You'll Do.
Assess new and changing computer systems
Conduct risk assessments
Review change requests
Oversee GMP documentation revisions
Act as QA CSV representative
Provide technical guidance
Perform all aspects of QMS process
Perform Gap assessments
Initiate Quality records
Execute CSV project lead responsibilities
Author/Review/Approve validation deliverables
Schedule qualification activities
Revise and maintain SOPs
Review Engineering documents
Support Validation requests
How You'll Work.
Team & Collaboration
Leads teams in assessing systems; Provides technical guidance and mentorship; Works independently and in teams; Work together every day
Process & Methodology
CSV project lead for projects
Full Job Description
_**Computer Systems Validation Specialist III**_ **Location:** Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed. The Computer Systems Validation (CSV) Specialist III leads teams in assessing new and changing computer systems to ensure compliance with company policies and industry guidance. They conduct risk assessments, review change requests and test scripts, draft protocols, and oversee GMP documentation revisions. This role acts as the QA CSV representative for small and large-scale projects while providing technical guidance and mentorship to junior team members. **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. * 401(k) matching plan. * Supportive leadership and mentoring. * Commitment to ethical and sustainable practices. Our full list of global benefits can be found here: [**https://www.lonza.com/careers/benefits**](https://www.lonza.com/careers/benefits)**.** **What you will do:** * Perform all aspects of QMS process’ – Change Control, Deviations, * CAPAs. * Perform Gap assessments to identify the gaps in processes and suggest remediation plans. Initiate the right Quality records (Deviations and CAPAs) to drive the remediation plan, as needed and execute all responsibilities as CSV project lead for projects. * Author/Review/Approve all end to end Computer system validation life- * cycle deliverables/activities. * Schedule qualification activities and personnel to meet business, * manufacturing, engineering and quality objectives. * Revise and maintain SOPs to ensure continuous improvement and * compliance to GROUP/CORP procedures. * Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.). * Support Validation requests as a CSV SME, during Customer audits and inspections. **What we are looking for:** * B
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