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Thermo Fisher Scientific · 2 days ago
Lab Validation Analyst
New Brunswick, NJ
Full-time
Onsite
Mid Level
3+ years exp
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Responsibilities
Apply FDA CFR 251 Prt 11/EU Annex 11 GAMP 5, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes and computer software assurance.
Follow SOPs and industry standard processes.
Review validation deliverables including requirement and design specifications, summary reports, pre/post executed test scripts and procedures in support of the system and potentially generate these deliverables as needed.
Maintain close communication with collaborators and team members to keep informed of computerized system needs, impact on computer validation, project validation status, and other relevant issues.
Lead, assist and conduct planning, implementing, and documenting user requirements, risk assessments, software and UAT testing.
Assist in supporting operational and compliance initiatives such as periodic reviews of systems, SOP updates, training materials, user requested enhancements, and system audit trail assessments.
Collaboration with various multi-functional colleagues (i.e., scientists, instrument vendors, QA, and IT colleagues) to evaluate new software or enhancement opportunities, setup and qualify new systems or upgrade existing systems in the ASO testing laboratories.
Authoring and driving relevant sections of GMP software qualifications.
Ability to manage and organize the workload for multiple projects simultaneously.
Develop standard operating procedures which ensure the integrity of both the laboratory data collected and the systems used to collect the data.
Support the smooth adoption of the software and enhancements.
Acting as the support of the standalone applications and ensuring harmonized configuration, versions, and software usage across geographies.
Qualification
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Required
Bachelor's degree in relevant field or equivalent
3+ years of hands-on IT support experience, with at least 1 year in a lab environment with a clear understanding of GMP laboratory operations and testing
Hands-on end user experience (i.e., system administrator or Super User on LIMS, Empower, ELN etc.)
Excellent oral and written communication skills in English. Once trained, can work independently on CSV, user requested upgrades/enhancements and continuous improvement projects with minimal oversight.
Ability to perform in a highly matrixed organization structure.
Possess Expertise on Good Documentation and Good Testing Practices and understanding of cGMPs and Computer System Validations.
Demonstrated experience installing, configuring, and supporting GMP systems and applications in lab environments. This includes instrument software applications.
Demonstrated creative and innovative solution with regards to compliance in CSV.
Preferred
Experience with electronic document management systems (e.g., Veeva platform, SharePoint etc.); application development and lifecycle management (e.g., HP ALM, ValGenesis, etc.)
Experience with one or more of the following: software testing and deployment, validation and UAT execution, and asset lifecycle management.
Knowledge of laboratory automation technologies such as standalone benchtop applications, statistical software (Slimstat or similar) and scientific data management systems (NuGenesis, MODA, or similar).
Benefits
Full-time benefits
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10,001+ employees
H1B Sponsorship
Thermo Fisher Scientific 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
Trends of Total Sponsorships
2023 (173)
2022 (314)
2021 (349)
2020 (251)
Funding
Current Stage
Public CompanyTotal Funding
$11.05BKey Investors
National Grid
2023-08-07Post Ipo Debt· $2.95B
2023-03-27Grant· $0.5M
2022-11-15Post Ipo Debt· $1.29B
Leadership Team
Daniella Cramp
Senior Vice President and President
Frederick Lowery
Senior Vice President Thermo Fisher and President Customer Channels
Recent News
2024-05-26
Company data provided by crunchbase
