706 validation engineer jobs at 309 companies in Hellertown, PA
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Validation Engineer
Montgomeryville, Pennsylvania, United States
OnsiteFull Time
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.
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.
Philadelphia or Harrisburg or Allentown or King of Prussia or Marietta or Fogelsville
$73k-$80k/yrOnsiteFull Time
CAI: Provides commissioning and compliance services for regulated manufacturing facilities.
2+ YOEBachelor's degree in science or engineering, or equivalent experience, plus 2–4 years in commissioning and qualification within a regulated industry; ISPE Baseline Guide 5 familiarity is a plus.
Kashiv BioSciences: Develops biosimilars and drug delivery systems for medicine improvement.
8+ YOEEngineering or pharmaceutical degree and 8+ years in medical device or FDA-regulated environments. Requires validation, quality systems, cGxP, ISO, technical writing, and Microsoft Office experience.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
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.
GSKLondon Stock Exchange: GSK: Develops and manufactures innovative vaccines and specialty medicines.
8+ YOE8+ years relevant technical experience with minimum 5+ years hands-on validation in regulated environments. Experience writing/executing IQ/OQ/PQ, Microsoft Windows configuration, process control systems, and databases. Bachelor's in engineering/life sciences/computer science (or associate + 8+ yrs).
CognizantNasdaq: CTSH: Provides IT consulting and digital business process services.
Experience with computerized system validation for lab systems, knowledge of 21 CFR Part 11, Annex 11, GAMP5, validation protocols (IQ/OQ/PQ), regulatory audits and technical writing.
Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Jira, Service Now, HP ALM
6424 - Lead Validation Engineer (Data Lake) / CSV Engineer
Conshohocken or Wayne
$88k-$136k/yrOnsiteFull Time
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
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.
Global Quality System Developer and Validation Analyst
Piscataway, New Jersey, United States
$86k-$121k/yrHybridFull Time
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.
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.
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.
Pennsylvania Liquor Control Board: Regulates alcohol distribution and operates state-owned wine and spirits stores.
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.
NewAge Industries: Manufactures high-purity tubing and fluid transfer components.
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.
Terracon: Provides geotechnical, environmental, construction, and facilities engineering services.
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.
Air ProductsNYSE: APD: Produces industrial gases and equipment for energy and manufacturing.
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.
SFS GroupSIX Swiss Exchange: SFSN: Manufactures precision components and fastening systems for industrial applications.
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.