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Original Job Post

myGwork - LGBTQ+ Business Community · 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

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

IT supportGMP operationsLIMSEmpowerELN Documentation Practices Testing PracticesCGMPsComputer System ValidationsConfiguringSupporting GMP systemsInstrument software applicationsComplianceCSVElectronic document management systemsVeeva platformSharePointApplication developmentLifecycle managementHP ALMValGenesisSoftware testingDeploymentValidationUAT executionAsset lifecycle managementLaboratory automation technologiesBenchtop applicationsStatistical softwareScientific data management systems

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

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)