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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)
3w
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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
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
1mo
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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
2mo
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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
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
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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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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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.
3w
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Engineer II
Reading, Pennsylvania, United States
HybridFull Time
3+ YOEBachelor's in civil engineering, EIT, valid driver's license, 3+ years municipal/civil engineering experience, AutoCAD Civil 3D and GIS proficiency, strong communication and project coordination skills.
AutoCAD Civil 3D, GIS
4d
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Civil Engineer Trainee
Norristown, Pennsylvania, United States
$68k-$81k/yr HybridFull Time
1+ YOEBachelor's in civil engineering or 1 year civil engineering experience plus valid Engineer-in-Training certificate; valid driver's license; ability to perform field inspections and technical analyses.
2mo
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Sustaining Engineer
Southampton, Pennsylvania, United States
OnsiteFull Time
3+ YOEBachelor’s in Mechanical, Biomedical, or Polymer Engineering; 3+ years in sustaining or related engineering in regulated industries; CAD, validation, GMP knowledge; strong problem-solving and communication.
SolidWorks, AutoCAD, CAD
1mo
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Field Engineer
Blue Bell, Pennsylvania, United States
FieldFull Time
Bachelor's degree in Engineering required. May require valid driver's license. Preferred: Engineer in Training (EIT). Duties include field investigations, data collection, CAD drafting, and report preparation.
CAD
1mo
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Process Engineer
St. Louis or Allentown
OnsiteFull Time
3+ YOEBachelor's in Chemical Engineering required; 3+ years process engineering experience; valid driver\u0002s license; membrane or gas processing experience preferred; willingness to travel (~10%); strong communication skills.
Aspen
1mo
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Quality Engineer
Wyomissing, Pennsylvania, United States
OnsiteFull Time
3+ YOE3+ years in engineering or quality/validation, experience with RCA and 8D, mechanical/corrosion testing exposure, familiarity with SAP and product tracking, interest in data analytics; bachelor's in mechanical/materials engineering recommended.
SAP
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Engineer,Quality
Turtle Creek or Edison
OnsiteFull Time
Bachelor's in engineering required; quality engineering or new product development experience preferred. Responsibilities include root cause analysis, FMEA, verification/validation testing, supplier qualification, audits, and design control documentation.
3w
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Senior Traffic Engineer
Allentown, Pennsylvania, United States
OnsiteFull Time
8+ YOEPA Professional Engineer license, 8+ years traffic engineering experience, bachelor's in civil/traffic engineering, project management and leadership experience, valid driver's license, proficiency with Synchro, HCS, and Vissim.
Synchro, HCS, Vissim
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