1mo
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Validation Lead
Morrisville or Durham
$126k-$234k/yr OnsiteFull Time
8+ YOE5+ MgmtBachelor's in a scientific discipline, 8 years in pharmaceutical manufacturing (5 years leading process validation), strong knowledge of process/cleaning validation, GMP, statistics, regulatory requirements, and cross-functional technical leadership.
Applied Statistics, Change Controls, Data Analytics and Digital (Inactive), GDP Knowledge (Inactive), Good Manufacturing Practices (GMP), HSE Knowledge (Inactive), Process and Cleaning Validation (Inactive), Process Control, Technology Transfer
2mo
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Validation Engineer
Raleigh, North Carolina, United States
OnsiteFull Time
1+ YOEBS/BA degree with 1-2 years in pharmaceutical or regulated industry validation; degrees in Biomedical, Chemical, or Mechanical Engineering preferred.
2w
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Cleaning Validation
Durham, North Carolina, United States
OnsiteFull Time
Develop and maintain cleaning validation programs, approve procedures and deliverables, support regulatory inspections, train personnel, and ensure compliance with regulatory and business standards.
2w
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Validation Engineer III
Durham, North Carolina, United States
OnsiteFull Time
5+ YOEBachelor's in science/engineering,5+ years executing validation in regulated manufacturing,knowledge of FDA expectations,CQV documentation experience,and ability to lead complex validation projects.
2w
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Validation Engineer - Experienced
Raleigh, North Carolina, United States
FieldFull Time
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.
Microsoft Office, Microsoft Project, AutoCAD
3w
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Specialist III, Validation
Holly Springs, North Carolina, United States
OnsiteFull Time
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
5d
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Sr. Validation Engineer
Raleigh, North Carolina, United States
OnsiteFull Time
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.
Computerized System Validation (CSV)
6d
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Validation Engineer - North Carolina
Durham, North Carolina, United States
OnsiteFull Time
5+ YOEBachelor's degree and 5+ years CSV experience in pharma/biopharma with MES, PLC, SCADA validation, knowledge of GxP, GAMP, 21 CFR Part 11, SDLC and data integrity.
Werum PAS-X, MES, Siemens, Allen-Bradley, Aveva Wonderware SCADA
2w
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Senior Engineer, Process Validation
United States or Boston or Dallas or Chicago or Sunnyvale or Houston or Indianapolis or Raleigh
$100k-$130k/yr RemoteFull Time
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%.
pFMEA, DOE
1mo
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Facilities and Validation Engineer
Durham, North Carolina, United States
OnsiteFull Time
1+ YOEOperate and maintain mechanical systems, manage equipment records/calibration in ERP/CMMS, perform equipment qualification/validation, support installations, and ensure cGMP/FDA compliance; biopharma experience required.
ERP, CMMS
3d
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Sr Engineer 1, Process Validation
Holly Springs, North Carolina, United States
OnsiteFull Time
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.
2mo
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Validation Team Manager (Raleigh, NC)
Raleigh, North Carolina, United States
OnsiteFull Time
Leadership of technical teams in temperature mapping/validation; CQV; GxP/ISO regulatory knowledge; project management; client/stakeholder engagement; English fluency; travel within the United States.
CQV tools, Temperature mapping software, IoT platforms
4d
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Sr Engineer 1, Process Validation
Holly Springs, North Carolina, United States
OnsiteFull Time
6+ YOEBachelor's in Engineering/Life Science/Chemical Engineering with 8 years experience or Master's with 6 years; process validation, PPQ, CQV, risk assessments, regulatory knowledge (FDA), and troubleshooting skills.
3w
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National Accounts Data Validation Specialist
Raleigh, North Carolina, United States
OnsiteFull Time
1+ YOE1–3 years data validation/auditing experience, high school diploma or GED minimum; Excel and Microsoft Office proficiency; SQL knowledge a plus; strong analytical and communication skills.
Microsoft Office, Microsoft Excel, SQL, Trux, Tower
5d
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Validation Area Specialist - Aseptic Production (AP)
Clayton, North Carolina, United States
OnsiteFull Time
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.
GAMP5
1mo
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Validation Specialist (Radiation Therapy) ** Onsite - Palo Alto**
Palo Alto or Los Angeles or Colorado Springs or San Diego or Dallas or Durham or Malvern or Austin or Atlanta or New York City or Seattle or Minneapolis or Denver or United States
$116k-$159k/yr OnsiteFull Time
5+ YOEClinical certification as a Radiation Therapist plus 5 years clinical experience OR B.A./B.S. plus 5 years radiation oncology/clinical applications experience; strong knowledge of radiation therapy workflows (IMRT, VMAT, SRS, SBRT), radiation safety, and product validation; ability to travel 5-25%.
ARIA Radiation Therapy Management software, Eclipse Treatment Planning System, TrueBeam, Halcyon, C-Series, RPM, RGSC, IDENTIFY
1mo
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Engineer 3, Commissioning Qualification Validation
Holly Springs, North Carolina, United States
OnsiteFull Time
5+ YOEBachelor's in Engineering with 5+ years validation/commissioning experience, experience leading projects, familiarity with temperature mapping and calibration, ability to read P&IDs, and experience with validation protocols and regulatory requirements.
CMMS, Tableau, P&IDs, Thermal Data Loggers
4w
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Staff Engineer – Process & Cleaning Validation
Zebulon, North Carolina, United States
OnsiteFull Time, Contract
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.
5d
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Validation Project Lead / Documentation Audit Lead
Durham, North Carolina, United States
OnsiteFull Time
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
2mo
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Post Silicon Validation Engineer II
Cary, North Carolina, United States
OnsiteFull Time
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.
Python, Bit-Error Rate Tests, Oscilloscopes, Spectrum Analyzers, Network Analyzers