Sr. Equipment Validation Engineer jobs in United States
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Katalyst CRO ยท 3 weeks ago

Sr. Equipment Validation Engineer

positionRaritan, NJ
timeFull-time
remoteOnsite
senioritySenior Level, Lead/Staff
date8+ years exp

Katalyst CRO is a confidential company seeking a Sr. Equipment Validation Engineer. The role involves monitoring lab instrument reviews, executing validations, and ensuring compliance with GMP standards while coordinating with various stakeholders.

AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Monitor due dates for lab instrument reviews and coordinate with stakeholders
Execute SOP-driven validations, produce IQ/OQ/PQ deliverables, and ensure ALCOA+ data integrity
Perform gap analyses, remediation plans, and efficiency enhancements for lab operations
Report metrics on validation status, closures, and compliance to internal teams
Coordinate system changes with QA/equipment owners, author validation protocols, and complete change documentation
Track periodic instrument reviews using schedulers, generate RTMs/VSRs, and finalize compliance artifacts
Lead team task assignments, deliver validation training, and drive multi-site demand planning for GMP upkeep

Qualification

GxP experienceHPLCIQ/OQ/PQ protocolsLIMS/Empower3Change controlCAPA handlingTechnical trainingStakeholder collaborationProcess improvements

Required

Minimum 8 years in GxP/analytical lab settings with hands-on validation of GMP instruments including HPLC, UV-VIS, FTIR, NMR, Polarimeter, XRD, Kaye Validators, and LIMS/Empower3 systems
Proven expertise in IQ/OQ/PQ protocols, RTM/VSR generation, SOP adherence, and 21 CFR Part 11/GAMP5 compliance
Experience leading offshore-onsite validation teams, assigning tasks, providing technical training, and managing multi-site equipment qualifications
Strong skills in change control (ServiceNow/Remedy), CAPA/deviation handling, gap analyses, and process improvements for lab efficiency
Ability to review/approve GMP deliverables (VMPs, test scripts, audit trails) in team environments with stakeholder collaboration and metrics reporting
Administer lab systems via ticketing (helpdesk, user access) while executing IQ/OQ/PQ for instruments like HPLC
Collaborate with analysts/owners to troubleshoot, validate, and resolve instrument issues per SOPs (onsite/remote)

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

LinkedIn
Katalyst HealthCares & Life Sciences on LinkedIn: Candidate Portal
2024-04-07
Company data provided by crunchbase