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Senior Validation Analyst jobs in United States
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Aequor · 1 day ago

Senior Validation Analyst

Aequor is seeking a Senior Validation Analyst to ensure that equipment, processes, and analytical methods are validated. The role involves providing quality engineering support throughout the product life cycle and conducting investigations for Non Conformance (NC) and Out Of Specification (OOS).
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H1B Sponsor Likelynote

Responsibilities

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 engineeringProcess risk managementTechnical documentationTeam collaborationOrganizational skillsInterpersonal skills

Required

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
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
Bachelor of Science Degree in relevant field (science, engineering, etc.)
5-7 years related experience or equivalent combination of education and experience

Company

Aequor

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Since 1998, Aequor has provided exceptional workforce staffing services in multiple industries.

H1B Sponsorship

Aequor 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 (2)
2024 (2)
2023 (1)
2022 (3)
2021 (1)
2020 (5)

Funding

Current Stage
Growth Stage

Leadership Team

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Kamalpreet S. Virdi
CEO & Chairman
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Company data provided by crunchbase