Lonza
Life Sciences
ComputerSystemsValidationSpecialistIII
“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
Applying for this Computer Systems Validation Specialist III role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Lonza?
Real rants from real employees. Read before you apply.