383 validation engineer jobs at 196 companies in Bunnlevel, NC
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Validation Engineer
Raleigh, North Carolina, United States
OnsiteFull Time
Performance Validation: Provides commissioning, qualification, and validation services for life sciences.
1+ YOEBS/BA degree with 1-2 years in pharmaceutical or regulated industry validation; degrees in Biomedical, Chemical, or Mechanical Engineering preferred.
PSC Biotech: Provides regulatory, quality, and engineering consulting services for life sciences.
7+ YOEBachelor's degree in a technical discipline and 7+ years of validation, commissioning, qualification, or quality engineering experience in FDA-regulated industries; KNEAT and CSV experience required.
KNEAT, Computer System Validation (CSV), GAMP 5, 21 CFR Part 11
Barry-Wehmiller: Manufactures industrial machinery for packaging and paper processing.
3+ YOE3+ years validation experience in automation, packaging, utilities or facilities; B.S. in engineering; strong technical writing, communications, and computer skills; willing to travel for project work.
Syner-G BioPharma Group: Provides CMC and regulatory services for life sciences companies.
7+ YOE7–11 years in biotech/pharma/medical devices, Bachelor's in life science or engineering, strong cGMP and CSV experience, expertise with IQ/OQ/PQ and validation documentation, audit support and technical leadership.
Valspec: Provides system validation and lifecycle services for life sciences companies.
Bachelor's degree in engineering or a related technical discipline; process validation and PPQ experience in biopharmaceutical or pharmaceutical manufacturing; technical writing, qualification coordination, GMP, process validation, and FMEA knowledge.
United States or Boston or Dallas or Chicago or Sunnyvale or Houston or Indianapolis or Raleigh
$100k-$130k/yrRemoteFull Time
DanaherNYSE: DHR: Develops scientific instruments and diagnostic tools for healthcare markets.
5+ YOEBachelor's degree in engineering,5+ years leading process validation in biologics,knowledge of cGMP and global regulatory requirements,statistical and risk tools (pFMEA,DOE),technical writing and root cause analysis,ability to travel ~15%.
Fujifilm SonositeTokyo Stock Exchange: 4901: Develops portable ultrasound systems for point-of-care medical diagnostics.
6+ YOEBachelor's in Engineering/Life Science/Chemical Engineering with 8 years experience or Master's with 6 years; experience in process validation, technology transfer, regulatory compliance, and manufacturing preferred.
Redmond or Mountain View or Austin or Hillsboro or Raleigh
$143k-$275k/yrHybridFull Time
MicrosoftNASDAQ: MSFT: Develops software, services, devices, and cloud computing solutions.
8+ YOEDegree in EE/CE/CS or equivalent with 8+ years experience; strong SoC/platform, validation, integration, and debug skills; security screening required; Python scripting and cross‑team collaboration experience.
PM Group: International project delivery firm for high-tech industrial facilities.
8+ YOEBachelor's in engineering/chemistry/life sciences, 8+ years process/cleaning validation in regulated sterile/aseptic manufacturing, strong cGMP knowledge, technical writing, data analysis, and cross-functional collaboration.
Cadence Design SystemsNASDAQ: CDNS: Develops computational software and hardware for electronic system design.
1+ YOEBS or MS in electrical/computer engineering; 1+ year validation in high-speed analog/mixed-signal; experience with BERT, oscilloscopes, spectrum analyzers, network analyzers; Python or OO language; strong communication and teamwork.
Verista: Provides compliance, automation, and validation services to life sciences.
4+ YOEBachelor's degree, 4+ years relevant CQV/validation experience in GMP environments, ability to mentor, strong written/oral communication, MS Office proficiency, able to work onsite in Raleigh/Durham, willing to travel 10–50%.
PC, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
PM Group: International engineering, architecture, and project management services firm.
8+ YOEBachelor's in engineering/chemistry/life sciences, 8+ years process or cleaning validation in regulated sterile/aseptic manufacturing, strong cGMP knowledge, PPQ experience, technical writing and analytical skills.
NovartisSIX Swiss Exchange, NYSE: NOVN, NVS: A global pharmaceutical focused on developing and manufacturing medicines and therapies.
8+ YOE5+ MgmtBachelor's in chemistry/pharmacy/chemical engineering/pharmaceutical technology,8 years manufacturing experience,5 years process validation leadership,expertise in process/cleaning validation,quality systems,applied statistics and global regulations.
Validation Area Specialist - Aseptic Production (AP)
Clayton, North Carolina, United States
OnsiteFull Time
Novo NordiskNYSE: NVO: Develops and manufactures medicines for diabetes and chronic diseases.
7+ YOEBachelor's in engineering/computer science or equivalent, 7+ years validation/quality experience in pharma, knowledge of 21 CFR Part 11 and GAMP5, ability to author/execute validation protocols and lead investigations.
CSLASX: CSL: Global biotechnology developing and manufacturing protein-based therapies and vaccines.
5+ YOE5+ years commissioning/qualification/validation experience, bachelor\u0002s in engineering/technical/science, DeltaV experience required; BAS, Data Historian, MES experience preferred; audit and contract staff experience preferred.
DeltaV, Data Historian, Building Automation System, Manufacturing Execution System
KBI Biopharma: Contract development and manufacturing for biopharmaceutical companies.
5+ YOEBachelor's or master's degree in engineering or information technology, 5–7 years of industry experience, lab equipment and IT computer validation experience, biotech cGMP knowledge, and project management skills.
Web applications, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, email
Validation Project Lead / Documentation Audit Lead
Durham, North Carolina, United States
OnsiteFull Time
FST Technical Services: Provides testing, inspection, and certification for mission-critical facilities.
8+ YOE3+ MgmtBachelor's in engineering or life sciences (or equiv),8+ years pharma validation/CQV/QA/GMP documentation experience,3+ years leading validation or CQV teams; knowledge of FDA cGMP, GDP, validation and audit support.
EIDA, Bluebeam, Microsoft Office, Microsoft SharePoint
GSKLondon Stock Exchange: GSK: Develops and manufactures innovative vaccines and specialty medicines.
10+ YOEBachelor's in chemistry/engineering/quality/pharmaceutical operations; minimum 10 years pharma experience and 7+ years validation experience; expertise in analytical method/equipment validation, project and team leadership, and laboratory/IT operations.
State of North Carolina: Provides essential public services and infrastructure for North Carolina.
4+ YOEBachelor's in engineering plus 4 years' progressive experience (or equivalent); valid driver's license; may require professional engineer (PE) registration; ability to perform technical engineering analysis and regulatory review.