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666 validation engineer jobs at 293 companies in Bethlehem, PA

1mo
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Validation Engineer
Montgomeryville, Pennsylvania, United States
OnsiteFull Time
Catalyx
Catalyx: Provides machine vision and automation solutions for manufacturing.
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
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3mo
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Validation Engineer
Branchburg, New Jersey, United States
$72k-$116k/yr HybridFull Time
Celltrion
CelltrionKorea Exchange: 068270: Develops and manufactures biopharmaceutical products and biosimilars.
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
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Validation Engineer
Reading, Pennsylvania, United States
OnsiteFull Time
Brentwood Industries
Brentwood Industries: Manufacturer of thermoformed plastic products for diverse industrial applications.
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
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1w
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Validation Engineer II
Branchburg, New Jersey, United States
$75k-$143k/yr OnsiteFull Time
AbbVie
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
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)
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2w
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Validation Engineer
North Carolina or Royersford
FieldFull Time
Valspec
Valspec: Provides system validation and lifecycle services for life sciences companies.
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
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3w
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(Sr.) Validation Engineer
Pennington, New Jersey, United States
$90k-$120k/yr OnsiteFull Time
GenScript
GenScriptHong Kong Stock Exchange: 1548: Provides gene synthesis and laboratory services for biotechnology research.
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
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Associate Validation Engineer (5523)
Cranbury, New Jersey, United States
$55k-$88k/yr OnsiteFull Time
WuXi Biologics
WuXi BiologicsHong Kong Stock Exchange: 2269: Provides discovery, development, and manufacturing services for biologic drugs.
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
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3w
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6424 - Lead Validation Engineer (Data Lake) / CSV Engineer
Conshohocken or Wayne
$88k-$136k/yr OnsiteFull Time
Verista
Verista: Provides compliance, automation, and validation services to life sciences.
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
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Senior Validation Engineer (I, II, III)
Bridgewater, New Jersey, United States
$90k-$210k/yr OnsiteFull Time
Cellares
Cellares: Automated manufacturing platform for large-scale cell therapy production.
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
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3mo
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Validation Engineering Roles
Philadelphia or King of Prussia
OnsiteFull Time
Barry-Wehmiller
Barry-Wehmiller: Manufactures industrial machinery for packaging and paper processing.
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
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Computer System Validation (CSV) Engineer
Piscataway, New Jersey, United States
OnsiteFull Time
Kashiv BioSciences
Kashiv BioSciences: Develops biosimilars and drug delivery systems for medicine improvement.
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
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2mo
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Validation Consultant
Princeton, New Jersey, United States
HybridFull Time
ZS
ZS: Global management consulting and technology firm for healthcare and life sciences.
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
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2mo
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EMS Validation Engineering Lead
Horsham, Pennsylvania, United States
$96k-$144k/yr OnsiteFull Time
Schneider Electric
Schneider ElectricEuronext Paris: SU: Provider of energy management and industrial automation solutions.
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
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4w
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Validation Specialist II
Telford, Pennsylvania, United States
OnsiteFull Time
Solesis
Solesis: Manufactures advanced biomaterials and textile components for medical devices
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.
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4w
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Validation Specialist II
Telford, Pennsylvania, United States
OnsiteFull Time
Secant Group
Secant Group: Develops and manufactures advanced biomaterials and medical textile components.
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
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2mo
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CSV Lead/ Computer System Validation Lead
Philadelphia or Marietta
OnsiteFull Time
GBA
GBA: Provides engineering, architecture, and construction services for infrastructure.
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
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Global Quality System Developer and Validation Analyst
Piscataway, New Jersey, United States
$86k-$121k/yr HybridFull Time
Colgate-Palmolive
Colgate-PalmoliveNYSE: CL: Manufactures and sells oral, personal, home, and pet care.
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
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2w
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Process & Validation Project Manager
Philadelphia, Pennsylvania, United States
OnsiteFull Time
Laporte
Laporte: Provides engineering services for pharmaceutical and food manufacturing facilities.
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
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Director, Software Validation - Hybrid - New Jersey
Hampton, New Jersey, United States
$90-$100/hr HybridContract
Slipstream IT
Slipstream IT: Provides IT managed services and consulting for life sciences organizations.
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.
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2w
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Engineer II
Reading, Pennsylvania, United States
HybridFull Time
ARRO Consulting
ARRO Consulting: Provides engineering, environmental, and municipal consulting services.
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
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