Sr. Validation Engineer, Process Validation jobs in United States
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Danaher Corporation · 5 months ago

Sr. Validation Engineer, Process Validation

positionFargo, North Dakota, United States
timeFull-time
remoteOnsite
seniorityMid, Senior Level
date3+ years exp

Aldevron, part of Danaher Corporation, is committed to advancing science and unlocking human potential. The Senior Validation Engineer, Process Validation role involves providing expertise and guidance in validation programs across biological materials and drug products, ensuring compliance with industry standards.

BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedical
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H1B Sponsor Likelynote

Responsibilities

Design, execute, and oversee validation documents supporting process characterization and validation spanning biological critical starting materials, drug substance, and drug product
Mentor junior validation associates in Process Validation, cGMP regulations, and principles of Quality by Design
Develop and implement validation policies and procedures based on current regulations and industry standards
Provide subject matter expertise during client and regulatory audits, kaizen and workshop events, and manufacturing support
Help resolve quality issues and CAPA’s leading lab investigations, risk assessments, root cause analysis, and developing implementation plans

Qualification

Process ValidationCGMP regulationsStatistical toolsRisk assessmentProcess improvementQuality by DesignRegulatory auditsRoot cause analysisMentoring

Required

Bachelor's degree in Engineering or Scientific field (preferably Chemical, Biology, or Microbiology) with 5+ years of experience or MS degree with 3+ years of experience
PhD in Engineering or Scientific field with 2+ years of experience
Experience in process development, engineering, and process validation required
Experience working in CDMO environment is a plus
Experience using statistical, risk assessment, and process improvement tools

Preferred

Working knowledge of current industry critical starting material, drug substance, and drug product regulatory guidelines

Benefits

Comprehensive, competitive benefit programs
Health care program
Paid time off

Company

Danaher Corporation

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Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health.
dateFounded in 1969
location
Washington, District of Columbia, USA
people-size10001+ employees
web-link
https://www.danaher.com/

H1B Sponsorship

Danaher Corporation 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 (7)
2024 (4)
2023 (3)
2022 (1)
2021 (2)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
unknown
1979-01-05IPO

Leadership Team

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Rainer Blair
President & CEO
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Thomas Joyce
President & CEO

Recent News

mass-spec-capital.com
Danaher Corporation. (1/5/26). "Press Release: Danaher to Present at J.P. Morgan Healthcare Conference". Washington, DC.
2026-01-09
Benzinga.com
$1000 Invested In Danaher 10 Years Ago Would Be Worth This Much Today
2026-01-08
PR Newswire
Danaher to Present at J.P. Morgan Healthcare Conference
2026-01-05
Company data provided by crunchbase