Validation Engineer II jobs in United States
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LanceSoft, Inc. · 3 weeks ago

Validation Engineer II

LanceSoft, Inc. is a company seeking a Validation Engineer II to contribute as an individual in identifying and implementing industry best practices. The role involves risk assessing systems, reviewing change requests and test scripts, and ensuring compliance with regulatory requirements and industry standards.

Information Technology
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Identify and implement industry best practices through an extensive industry network and detailed knowledge of applicable regulations
Work with other experienced members of the CSV team to identify roadblocks and additional efficiencies during the scoping portion of improvement projects
Risk assessing systems, reviewing change requests and test scripts, drafting protocols and initiating and reviewing GMP documentation revisions
Execute all responsibilities as the CSV owner for significant site and process improvement projects, to ensure compliance to appropriate regulatory requirements and industry standards while maximizing efficiency
Perform all aspects of QMS process’ – Change Control (particularly associated with DCS ( DeltaV) and MES ( Syncade) systems, Deviations, CAPAs
Perform other duties as assigned

Qualification

Equipment validationControls AutomationProcess Control SystemsManufacturing Execution SystemsBiotech/Pharma experienceDeadline managementAttention to detailIndependent work

Required

Substantial experience in equipment and/or computer validations
Working experience with Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES) required
Prior experience leading projects in a Biotech/Pharma or biologics industry
Strong attention to detail and ability to work independently and meet deadlines successfully

Preferred

DeltaV

Company

LanceSoft, Inc.

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Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.

H1B Sponsorship

LanceSoft, Inc. 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 (55)
2024 (32)
2023 (23)
2022 (25)
2021 (60)
2020 (80)

Funding

Current Stage
Late Stage

Leadership Team

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Ram Karuppusamy
Chairman & CEO
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Simon Dealy
Chief Financial Officer
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Company data provided by crunchbase