BSA III - Validation Analyst jobs in United States
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Milestone Technologies, Inc. · 22 hours ago

BSA III - Validation Analyst

Milestone Technologies, Inc. is seeking an experienced Computer Systems Validations Analyst with strong GMP computerized validation expertise. The role focuses on supporting compliance, data integrity, and validation activities related to laboratory IT systems and software environments in a pharmaceutical or biotechnology setting.

Application Performance ManagementConsumer ElectronicsInformation Technology
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Responsibilities

Lead and support GMP validations including IQ/OQ for laboratory instrument control systems and related software
Manage multiple simultaneous validations (currently ~5 projects) including system requalification due to server migrations and Windows OS upgrades
Plan, execute, and validate upgrades of lab IT assets from Windows 10 to Windows 11
Configure and deploy Windows-based lab systems using predefined images; work closely with scientists for functional testing, acceptance, and regulatory validation steps
Maintain IT asset inventory and documentation through ServiceNow
Support service transitions such as USLV to USTO server migrations, triggering requisite GMP qualifications and revalidations on impacted documentation and systems
Support, maintain, and troubleshoot analytical instrument software platforms such as Empower, Chromeleon, Thermal, Nimbus/Nimbo, Echo, and assist in the transition from Teamo to Omnus anticipated in 2026
Utilize specialty applications and enterprise systems including Veeva and CDOCS, ensuring adherence to data integrity standards
Configure data management tools to automate data transfers from lab instruments to enterprise file shares
Lead data integrity assessments using standardized templates to ensure compliance and flexibility for early-stage evaluations
Manage incident tickets related to lab software and hardware, including user account and licensing management
Participate in activities such as review of temperature mapping documentation and PM job walks using Smartsheet or similar systems
Partner with instrument vendors for setup, configuration, and upgrades of lab instrumentation systems
Document validation activities, system changes, and issue resolutions in compliance with regulatory standards and corporate policies

Qualification

GMP validationLaboratory software expertiseWindows OS upgradesData integrity systemsAnalytical instrumentsMulti-taskingCommunication skills

Required

Bachelor's degree preferred; 5+ years of experience in lab operations or bio/pharmaceutical industry strongly preferred
Proven experience with GMP computer system validation and qualification processes including IQ/OQ
Hands-on experience with laboratory analytical instruments and associated software platforms (Empower, Chromeleon, Nimbus, Echo, Thermal)
Knowledge of laboratory IT infrastructure and experience with Windows OS upgrade projects
Familiarity with compliance and data integrity systems such as Veeva and CDOCS
Ability to multi-task on overlapping projects including server migrations, validations, and software rollouts
Strong communication skills to collaborate effectively with scientists, vendors, and IT teams

Benefits

No PTO and No Paid Holidays

Company

Milestone Technologies, Inc.

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Milestone Technologies is a global IT Services and Digital Solutions company based in Silicon Valley that helps hundreds of leading corporations deliver technology around the globe.

Funding

Current Stage
Late Stage
Total Funding
$42.5M
Key Investors
H.I.G. Capital
2022-12-13Acquired
2015-08-11Private Equity· $42.5M

Leadership Team

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Sameer Kishore
President and Chief Executive Officer
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Mayank K Agrawal
Chief Financial Officer
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Company data provided by crunchbase