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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
3mo
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Validation Engineer
Branchburg, New Jersey, United States
$72k-$116k/yr HybridFull Time
0+ YOEKnowledge of cGMPs, validation lifecycle, data integrity (ALCOA+); develop/execute qualification/validation documents; bachelor’s degree in engineering/computer science/science; 0–5 years validation experience; MS Office proficiency; TrackWise/Maximo/LIMS a plus.
Microsoft Word, Microsoft Excel, Microsoft Project, Microsoft Outlook, Kaye Validator, TrackWise, Maximo, LIMS
1w
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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)
3w
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Validation Engineer
Fairfield, New Jersey, United States
$100k-$110k/yr OnsiteFull Time
5+ YOE5+ years product quality/validation experience in medical device/GxP industry, PPAP/validation deliverables, ISO13485/21 CFR 820/GMP knowledge, GD&T and blueprint reading, Minitab and Microsoft Office proficiency.
Minitab, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
2w
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Validation Engineer
North Carolina or Royersford
FieldFull Time
5+ YOEBachelor's in engineering or equivalent experience, 5+ years CQV/commissioning in biopharma, hands-on downstream equipment and DeltaV/DCS experience, strong cGMP knowledge, P&ID proficiency, field commissioning and troubleshooting skills.
DeltaV, Emerson
3w
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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
3w
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Associate Validation Engineer (5523)
Cranbury, New Jersey, United States
$55k-$88k/yr OnsiteFull Time
BS in engineering or science (or equivalent experience); experience in FDA-regulated industry or equipment qualification/validation; understanding of cGMP/GXP/GAMP, 21CFR part 11, computer systems validation and SDLC; technical writing and strong communication skills.
Kaye Validator, clamp meter, RTD probe, Process Control Systems Validation (CSV), Software Development Life Cycle (SDLC), 21CFR part 11
3w
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6424 - Lead Validation Engineer (Data Lake) / CSV Engineer
Conshohocken or Wayne
$88k-$136k/yr OnsiteFull Time
8+ YOEBachelor's in CS/Engineering/Info Systems/Life Sciences, 8+ years CSV/CSA/IT compliance experience in regulated industries, cloud platform validation experience, knowledge of GAMP5/21 CFR Part 11/Annex 11, documentation and stakeholder management.
Microsoft Azure, Azure Data Lake Storage, Azure Data Factory, Databricks, Microsoft Fabric, Power BI
1mo
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Senior Validation Engineer (I, II, III)
Bridgewater, New Jersey, United States
$90k-$210k/yr OnsiteFull Time
8+ YOEBachelor's degree in Engineering or a scientific field; 8+ years GMP validation; 5+ years qualification/validation hands-on; knowledge of 21 CFR Parts 210,211, 820; 21 CFR Part 11; GAMP5; strong documentation; collaborative in agile environments.
IQ/OQ/PQ, GAMP5, 21 CFR Part 11, CSV, ALCOA+, Risk Assessments, URS
3mo
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Validation Engineering Roles
Philadelphia or King of Prussia
OnsiteFull Time
Experience in validation of automation, packaging, drug-substance/product systems; FDA compliance experience; bachelor’s in engineering; strong technical writing; willing to travel.
Emerson DeltaV, Syncade, Allen-Bradley PLC, Wonderware, OSI PI, Rockwell Automation, AutoCAD, Microsoft Project, Microsoft Office
1mo
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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
2mo
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Validation Consultant
Princeton, New Jersey, United States
HybridFull Time
6+ YOE6-10 years in Computer System Validation (CSV) within GxP environments; bachelor’s or master’s in Engineering/Science/Medical; willing to travel up to 20%; strong knowledge of global regulations and CSV/CSA risk assessments.
JIRA, HP ALM, Solution Manager, Kneat, SQL
2mo
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EMS Validation Engineering Lead
Horsham, Pennsylvania, United States
$96k-$144k/yr OnsiteFull Time
10+ YOE10+ years’ GMP validation/quality in pharma; 4-year engineering/technical degree; certifications: EcoStruxure Building WorkStation, System Design, Technician; CQE/CVP/CPIP preferred; GAMP5 training preferred.
Microsoft Office, MS Project, Visio
4w
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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.
4w
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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
2mo
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CSV Lead/ Computer System Validation Lead
Philadelphia or Marietta
OnsiteFull Time
10+ YOEBS in engineering,10+ years project/process engineering or validation experience,pharmaceutical/GMP experience preferred,Kneat and MS Office proficiency,excellent communication and problem-solving skills.
Kneat, Microsoft Excel, Microsoft Word, Microsoft Project, Microsoft PowerPoint, Microsoft Access
1mo
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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
2w
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Process & Validation Project Manager
Philadelphia, Pennsylvania, United States
OnsiteFull Time
5+ YOEBachelors in engineering or equivalent; 5+ years preparing and executing IQ/OQ/PQ; strong GMP, project management, communication, and technical skills; flexibility to travel to client sites.
ISPE GAMP5, 21 CFR Part 11
1w
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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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Assistant Engineer
Staten Island, New York, United States
$54-$55/hr OnsiteFull Time
1+ YOE3rd Assistant Engineer Unlimited Oceans or Chief Engineer (limited) or Assistant Engineer (limited) Oceans or Near Coastal; STCW endorsements; current Medical Certificate; valid passport; valid TWIC.
MS Office
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