Computer Systems Validation (Analytical Equipment), Specialist III jobs in United States
cer-icon
Apply on Employer Site
company-logo

Lonza · 1 day ago

Computer Systems Validation (Analytical Equipment), Specialist III

positionPortsmouth, NH
timeFull-time
remoteOnsite
seniorityMid Level
date3+ years exp

Lonza is a global leader in life sciences manufacturing, and they are seeking a Computer Systems Validation Specialist III to ensure compliance with industry standards. The role involves leading validation processes for analytical equipment, managing assessments, and providing cross-functional leadership within a collaborative environment.

BiotechnologyLife SciencePharmaceutical
check
H1B Sponsor Likelynote

Responsibilities

Lead end-to-end validation for analytical equipment as a Subject Matter Expert (SME), ensuring strict adherence to cGMP and quality standards
Manage Computer System Validation (CSV) and Data Integrity (DI) assessments for all system changes and existing computerized platforms
Execute validation maintenance through periodic reviews and the authorship of Validation Plans, Reports, and Master Plans
Review and approve technical protocols, including IQ/OQ/PQ and TrackWise quality records, to ensure compliance
Conduct specialized risk assessments, including ERES, Data Integrity Risk Assessments (DIRA), and Audit Trail Risk Assessments (ATRA)
Drive gap remediation by identifying process deficiencies and managing Deviations and Corrective and Preventive Actions (CAPA)
Provide cross-functional leadership by mentoring junior specialists and collaborating with teams to ensure on-time closure of quality records

Qualification

Computer Systems ValidationCGMP complianceRisk assessments21 CFR Part 11ISPE GAMP guidelinesAnalytical equipment validationBackground in biotechTeam collaborationMentoringIndependent work

Required

Bachelor's degree in computer science, engineering, or related field
At least 3+ years of experience in computer systems validation
3 + years of Experience in working in a cGMP facility
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation (especially for analytical computerized systems)
Works independently and in teams
Background in biotech, pharma, or medical device industry
Ability to work independently and on-site in Portsmouth NH

Benefits

Competitive compensation and benefits package.
401(k) matching plan.

Company

Lonza

twittertwittertwitter
Glassdoor3.6
company-logo
Lonza Group supplies products and services to pharmaceutical and agrochemical industries.
dateFounded in 1897
location
Basel, Basel-Stadt, CHE
people-size10001+ employees
web-link
http://www.lonza.com

H1B Sponsorship

Lonza has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2022 (1)
2021 (3)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$444.8M
2023-11-06Post Ipo Debt· $444.8M
2020-12-07IPO

Leadership Team

leader-logo
Wolfgang Wienand
Chief Executive Officer
linkedin
leader-logo
Alfons Ehinger
Founder

Recent News

PR Newswire
Lonza's Synaffix and Sidewinder Therapeutics Announce Multi-Target License Agreement to Advance Development of Next-Generation Bispecific ADCs
2026-01-07
PharmiWeb
Global High Potency API CDMOs Market Overview
2026-01-07
GlobeNewswire
Why Respiratory Vaccines Remain a Strategic Focus for Healthcare Systems Worldwide?
2026-01-05
Company data provided by crunchbase