Senior Lab Instruments Software Validation Analyst / Technical Writers jobs in United States
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Katalyst CRO ยท 2 months ago

Senior Lab Instruments Software Validation Analyst / Technical Writers

positionHighland Heights, KY
timeContract
remoteOnsite
senioritySenior Level, Lead/Staff
date10+ years exp

Katalyst CRO is seeking an experienced Lab Instruments Software Validation Analyst with expertise in the clinical research industry. The role involves ensuring the reliability and regulatory compliance of laboratory instrument software and computerized systems used in clinical trials.

AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Lead and execute validation protocols (DQ, IQ, OQ, PQ) for analytical instruments and laboratory software
Design and implement integration, regression, and performance testing strategies
Oversee validation execution in GxP facilities, ensuring compliance with SOPs and international standards
Author, review, and maintain validation life cycle documentation, including URS, FRS, Traceability Matrix, Risk Assessments, Validation Summary Reports, SOPs, and technical specifications
Ensure validation deliverables comply with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and internal policies
Conduct periodic system reviews and manage revalidation activities
Perform in-depth risk assessments and gap analyses to mitigate compliance risks
Lead investigations into deviations and ensure effective Corrective and Preventive Actions (CAPA) are implemented
Collaborate with Quality Assurance, R&D, Production, IT, and global teams to deliver validation outcomes
Partner with software/hardware development teams for issue resolution and debugging
Mentor and train junior analysts, foster knowledge sharing and best practices

Qualification

Analytical instrument validationRegulatory complianceEquipment qualificationRisk assessmentValidation documentationTechnical writingLeadership skillsCollaboration skills

Required

10+ years of proven expertise in the clinical research industry
5+ years of hands-on, specialized experience in analytical instrument/software validation and equipment qualification
In-depth knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), cGMP, and regulatory guidelines such as FDA 21 CFR Part 11 and EU Annex 11
Strong leadership and cross-functional collaboration skills
Lead and execute validation protocols (DQ, IQ, OQ, PQ) for analytical instruments and laboratory software
Design and implement integration, regression, and performance testing strategies
Oversee validation execution in GxP facilities, ensuring compliance with SOPs and international standards
Author, review, and maintain validation life cycle documentation, including URS, FRS, Traceability Matrix, Risk Assessments, Validation Summary Reports, SOPs, and technical specifications
Ensure validation deliverables comply with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and internal policies
Conduct periodic system reviews and manage revalidation activities
Perform in-depth risk assessments and gap analyses to mitigate compliance risks
Lead investigations into deviations and ensure effective Corrective and Preventive Actions (CAPA) are implemented
Collaborate with Quality Assurance, R&D, Production, IT, and global teams to deliver validation outcomes
Partner with software/hardware development teams for issue resolution and debugging
Mentor and train junior analysts, foster knowledge sharing and best practices
10+ years of progressive experience in laboratory instrument and software validation within the clinical research, pharmaceutical, or biotechnology industry
5+ years of hands-on expertise in analytical instrument systems validation (e.g., spectroscopy, chromatography, protein analyzers, next-gen sequencers, PCR systems)
Equipment qualification (DQ, IQ, OQ, PQ) and computerized system validation
Regulatory compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GAMP 5
Risk assessment, root cause analysis, and CAPA management
Validation documentation authoring and review (Validation Plans, URS/FRS, Risk Assessment Documents, Traceability Matrices, Validation Summary Reports)
Process improvement and SOP/work practice development in validation life cycle management
Strong leadership skills with the ability to manage multiple validation projects simultaneously
Excellent communication, technical writing, and collaboration skills across global teams

Company

Katalyst CRO

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Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
location
South Plainfield, New Jersey, USA
people-size51-200 employees
web-link
http://katalysthls.com

H1B Sponsorship

Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)

Funding

Current Stage
Growth Stage

Leadership Team

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John Patil
Recruiter, Pharma/CRO Staffing Division
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Recent News

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Katalyst HealthCares & Life Sciences on LinkedIn: Candidate Portal
2024-04-07
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