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Validation Senior Analyst V jobs in United States
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TekWissen ® · 18 hours ago

Validation Senior Analyst V

TekWissen Group is a workforce management provider, and they are seeking a Validation Senior Analyst V for a contract position. The role involves ensuring equipment, processes, and analytical methods are validated, as well as providing quality engineering support throughout the product life cycle.
Information Technology
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Venkat J Swaroop
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Responsibilities

Responsible for ensuring that equipment, process and analytical methods are validated
Support production by providing ongoing quality engineering support throughout the product life cycle and perform Non Conformance (NC) and Out Of Specification (OOS) investigations
Review and execute Installation (IQ), Operation (OQ) and Performance Qualification (PQ), test method validation protocols (TMV) and analytical test methods
Provide guidance/direction to teams upon review of validation documentation. Serve as a “hands-on” Validation Lead for Validation of changes to existing processes, systems and equipment
Review equipment manuals, specifications, drawings and operational documents to ensure validation and qualification protocols and standard operating procedures are in-line with manufacturer’s specifications, operational procedures, calibration requirements and required maintenance
Perform Non Conformance (NC) and Out Of Specification (OOS) investigations
Analyze processes and methods related to quality improvement (e.g. Six Sigma, statistical tools, etc.), product and process risk management (PFMEA) and corrective and preventive action (CAPA)
Assist with audits, explaining validation and qualification activities performed at the site

Qualification

Validation protocolsAnalytical methodsQuality engineeringRisk managementTechnical documentationTeam collaborationOrganizational skillsInterpersonal skills

Required

Bachelor of Science Degree in relevant field (science, engineering, etc.)
5-7 years related experience or equivalent combination of education and experience
Proven ability to write technical documentation
Proven ability to write analytical methods requirements and tests
Able to lead and prioritize tasks and to drive projects to completion
Ability to communicate in a clear, concise manner including previous experience in writing technical documentation
Able to work in a team environment
Possess strong organizational and interpersonal skills

Company

TekWissen ®

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Welcome TekWissen, your premier partner in technology consulting, workforce solutions, payroll services, procurement, managed services, global capability centers, and venture capital support, specifically tailored for startups in the human capital sector.

H1B Sponsorship

TekWissen ® 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 (5)
2024 (18)
2023 (11)
2022 (9)
2021 (16)
2020 (17)

Funding

Current Stage
Late Stage

Leadership Team

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Rajanish Pandey
Client Partnership Manager
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Company data provided by crunchbase