CSV Engineer jobs in United States
cer-icon
Apply on Employer Site
company-logo

Novozen Healthcare LLC ยท 1 day ago

CSV Engineer

positionIndiana, United States
timeContract
remoteOnsite
senioritySenior Level
date5+ years exp

Novozen Healthcare LLC is a company focused on the biotechnology and pharmaceutical sectors, and they are seeking a CSV Engineer to ensure the qualification and validation of laboratory analytical instruments. The role involves supporting the full instrument lifecycle, including compliance activities and ongoing system support.

BlockchainHealth CareInformation TechnologyIT InfrastructurePenetration TestingSoftwareStaffing AgencyWeb Development
check
H1B Sponsor Likelynote
Hiring Manager
Sirisha Adduri
linkedin

Responsibilities

Execute Computer System Validation (CSV) activities and laboratory instrument qualification
Author, review, and maintain validation documentation, including protocols and reports
Support system administration tasks such as user access management, system upgrades, and configuration control
Perform compliance activities, including periodic reviews and audit trail reviews
Configure and, when required, install software associated with laboratory instruments
Provide technical support throughout the instrument lifecycle, including defining IT infrastructure requirements such as data backup and recovery strategies
Develop and maintain standard operating procedures (SOPs) for equipment operation and system use
Collaborate with cross-functional teams and external vendors to address validation and compliance requirements
Participate in data integrity initiatives related to computer systems and secure desktop installation and configuration

Qualification

Computer System Validation (CSV)GMP-regulated laboratory experience21 CFR Part 11 knowledgeCompliance tools GMARSCompliance tools TrackWiseCompliance tools KneatWritten communicationVerbal communicationInterpersonal skillsAttention to detailOrganizational skills

Required

Minimum of 5 years of experience in Computer System Validation (CSV) for laboratory analytical instruments
Strong knowledge of 21 CFR Part 11 and experience working in a GMP-regulated laboratory environment
Familiarity with compliance and quality systems tools such as GMARS, TrackWise, and Kneat
Excellent written and verbal communication skills
Strong interpersonal skills with the ability to work effectively across teams
Highly organized with strong attention to detail and accuracy
Bachelor's degree in Biology, Chemistry, Engineering, Computer Science, or a related scientific or technical discipline

Company

Novozen Healthcare LLC

twittertwitter
company-logo
At Novozen Healthcare, we excel in bridging the gap between academics and industry.
dateFounded in 2018
location
South Plainfield, New Jersey, USA
people-size201-500 employees
web-link
https://novozen.com

H1B Sponsorship

Novozen Healthcare LLC 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
2025 (47)
2024 (34)
2023 (20)
2022 (1)

Funding

Current Stage
Growth Stage

Leadership Team

leader-logo
Vijay Kumar
Sr. Recruitment Partner
linkedin
Company data provided by crunchbase