1mo
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Validation Engineer
Montgomeryville, Pennsylvania, United States
OnsiteFull Time
3+ YOEBachelor's in Electrical or Electronic Engineering and 3+ years as an Automation/Validation Engineer; experience with PLC, DCS, HMI, validation protocols, control system design, programming, testing, and troubleshooting.
PLC, DCS, HMI
1mo
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Validation Engineer
Reading, Pennsylvania, United States
OnsiteFull Time
2+ YOEMinimum 2 years quality/validation engineering in manufacturing (plastics preferred). Bachelor’s in engineering preferred. Hands-on IQ/OQ/PQ experience, ISO 9001 knowledge, Microsoft Office and QMS proficiency, strong communication and auditing skills.
Microsoft Office, QMS software
2w
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Validation Engineer II
Branchburg, New Jersey, United States
$75k-$143k/yr OnsiteFull Time
3+ YOEPrepare and execute commissioning/qualification (IQ/OQ/PQ), develop validation documentation, support cleaning validation and CAPA investigations; 3+ years validation/engineering experience preferred; cGMP familiarity.
Kneat, Computer Maintenance Management System (CMMS)
1mo
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Validation Specialist II
Telford, Pennsylvania, United States
OnsiteFull Time
2+ YOEBachelor's in science/engineering required; 2+ years software validation experience (writing URS, risk assessments, validation protocols); IOQ experience preferred; knowledge of regulated QMS (FDA, ISO 13485), web-based software and databases, and software validation standards.
1mo
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Validation Specialist II
Telford, Pennsylvania, United States
OnsiteFull Time
2+ YOEBachelor's in science/engineering required, 2+ years software validation experience (2-5 preferred), IOQ experience preferred, ability to write URSs, risk assessments and validation protocols, knowledge of FDA/ISO requirements and web-based software.
FDA 21CFR Part 11, ISPE GAMP5
1mo
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(Sr.) Validation Engineer
Pennington, New Jersey, United States
$90k-$120k/yr OnsiteFull Time
9+ YOEBS/MS in life science, 9+ years GMP validation/engineering experience in drug/biologics, CQV experience, familiarity with CSV/GAMP 5 and 21 CFR Part 11, IQ/OQ/PQ protocol authoring, aseptic fill/finish experience preferred.
GAMP 5, 21 CFR Part 11, CSV
4d
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Technical Services – Cleaning Validation
Sellersville, Pennsylvania, United States
OnsiteFull Time
1+ YOEExecute cleaning validation sampling, follow GMP protocols, document and trend data, support investigations and audits. Associates preferred; 1+ years pharmaceutical/validation experience preferred; Microsoft Office proficiency.
Microsoft Office
1mo
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Model Risk & Validation Lead
New York City or Bethlehem
$103k-$170k/yr HybridFull Time
5+ YOE5+ years in insurance or financial services with model validation, strong technical skills with modeling platforms, leadership and communication ability; FSA preferred.
1mo
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6420 - Senior CSV Engineer / Senior Validation Engineer
King of Prussia or Wayne
$70k-$118k/yr OnsiteFull Time
5+ YOE5+ years CSV/CSA experience in regulated life sciences; lead validation strategy and lifecycle deliverables; strong SAP/S/4HANA and enterprise platform validation experience; familiarity with GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+ and SDLC.
SAP S/4HANA, ECC, MES, LIMS, Veeva, TrackWise, CMDB, GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, SDLC
2mo
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Senior Quality Validation Specialist
Bridgewater, New Jersey, United States
$90k-$210k/yr OnsiteFull Time
6+ YOEBachelor's degree; 5-8 years GMP in pharma/biologics; 2+ years quality/validation; strong GMP knowledge; CSV experience a plus.
CSV, GMP, Regulatory Knowledge
3w
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Data Validation Risk - Director
New York City or Atlanta or Charlotte or Chicago or Washington or Boston or Florham Park or Dallas or Philadelphia
$155k-$410k/yr OnsiteFull Time
8+ YOEBachelor's degree, at least 8 years' experience, expertise in data validation, analytics, visualization, and client leadership; familiarity with databases, cloud platforms, and ML tools preferred.
Alteryx, Python, Power BI, Tableau, Databricks, MS SQL, AWS, Azure, GCP, SAS
4d
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Lab Systems Validation Consultant
Spring House, Pennsylvania, United States
$90k-$109k/yr HybridFull Time
Bachelor's degree in a related field, hands-on CSV experience in regulated life sciences, knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, GxP, validation deliverables, and stakeholder communication.
Jira, ServiceNow, HP ALM
4d
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Lab Systems Validation Consultant
Spring House, Pennsylvania, United States
$90k-$109k/yr HybridFull Time
CSV experience in regulated life sciences, knowledge of FDA 21 CFR Part 11/EU Annex 11/GAMP 5/GxP, validation document preparation (IQ/OQ/PQ/RTM), strong technical writing and stakeholder skills.
Jira, ServiceNow, HP ALM, GAMP 5, SDLC, AI
1mo
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Validation Specialist (Radiation Therapy) ** Onsite - Palo Alto**
Palo Alto or Los Angeles or Colorado Springs or San Diego or Dallas or Durham or Malvern or Austin or Atlanta or New York City or Seattle or Minneapolis or Denver or United States
$116k-$159k/yr OnsiteFull Time
5+ YOEClinical certification as a Radiation Therapist plus 5 years clinical experience OR B.A./B.S. plus 5 years radiation oncology/clinical applications experience; strong knowledge of radiation therapy workflows (IMRT, VMAT, SRS, SBRT), radiation safety, and product validation; ability to travel 5-25%.
ARIA Radiation Therapy Management software, Eclipse Treatment Planning System, TrueBeam, Halcyon, C-Series, RPM, RGSC, IDENTIFY
2mo
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Computer System Validation (CSV) Engineer
Piscataway, New Jersey, United States
OnsiteFull Time
5+ YOEPlan, author, and execute CSV validation across regulated systems; ensure compliance with 21 CFR Part 11, EMA/GxP; collaborate across IT, QA, Lab, and Manufacturing.
Caliber LIMS, SAP, BMRAM, IQ/OQ/PQ
1w
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Manager, IT Validation Services
Princeton, New Jersey, United States
$90k-$110k/yr OnsiteFull Time
6+ YOEBachelor's in STEM,6+ years relevant experience,CSV and GxP expertise,experience with document management, ALM/JIRA and ServiceNow,test automation and agile CSV,strong communication and critical thinking.
Qumas, Veeva, SharePoint, ALM, JIRA, ServiceNow
1w
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Manager, IT Validation Services
Princeton, New Jersey, United States
$90k-$110k/yr OnsiteFull Time
6+ YOEBachelor's in STEM,6+ years relevant experience,experience with CSV for GxP systems,knowledge of electronic document management,application lifecycle and IT service management,agile CSV and test automation skills.
Qumas, Veeva, SharePoint, ALM, JIRA, ServiceNow
5d
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In Vivo Training and Validation Specialist
King of Prussia, Pennsylvania, United States
HybridFull Time
5+ YOE5+ years lab animal experience (or HS/GED with 10+ years), ability to train staff on in vivo techniques, execute equipment validation, maintain training records, comply with occupational health clearances.
2w
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Director, Software Validation - Hybrid - New Jersey
Hampton, New Jersey, United States
$90-$100/hr HybridContract
10+ YOEBachelor's or Master's in CS/Engineering/Life Sciences,10+ years CSV experience in GxP environments, expertise with GAMP 5, 21 CFR Part 11, Annex 11, CSA, and knowledge of GMP/GCP/GLP; leadership and cross-functional program management.
2mo
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Global Quality System Developer and Validation Analyst
Piscataway, New Jersey, United States
$86k-$121k/yr HybridFull Time
3+ YOEBachelor's in CS/Information Systems/Life Sciences or related, 3+ years as SME in global digital quality systems, GxP and FDA 21 CFR Part 11/EMA Annex 11 familiarity, CSV/CSA experience, proficiency with enterprise QMS (Veeva Vault/TrackWise/ETQ), LIMS, ERP, APIs/middleware.
Veeva Vault, TrackWise, ETQ, LIMS, ERP, QMS, API, middleware