3w
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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.
1w
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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.
1mo
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Specialist I, Validation
Holly Springs, North Carolina, United States
OnsiteFull Time
0+ YOEBachelor's degree preferred in engineering or science; 0-2 years commissioning/qualification/validation experience; develop and execute validation protocols, collect samples, program temperature monitoring devices, lead deviation investigations, and coordinate validation activities.
Kaye Validator, Lives loggers
1w
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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.
1w
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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
2w
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Advanced Quality / Validation Engineer
Clayton, North Carolina, United States
OnsiteFull Time
8+ YOE8+ years CQV/validation experience in pharma/biotech, bachelor's or master's in engineering or life sciences, strong GMP/GAMP5/ASTM E2500 knowledge, PQM/quality leadership, and client-facing skills.
GAMP 5, ASTM E2500, ISPE Baseline Guides
1w
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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
1w
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Process Validation Engineer
Raleigh or Durham
$70-$80/hr OnsiteContract
5+ YOEBS in engineering, 5+ years pharmaceutical/biotech GMP process or manufacturing engineering experience, hands-on upstream/downstream/clean utilities experience, cGMP knowledge, able to work onsite in Raleigh-Durham.
3mo
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Mgr Quality Validation (Raleigh, US)
Raleigh, North Carolina, United States
OnsiteFull Time
10+ YOE8+ MgmtLead the Validation Team ensuring cGMP FDA/EMEA compliance; manage qualifications, validations, change controls for equipment, systems, and processes.
4w
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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
1mo
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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
2w
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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
1w
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Engineer 3, Process Validation
Holly Springs, North Carolina, United States
OnsiteFull Time
3+ YOEBachelor's/Master's/PhD in engineering or life sciences with 3–5+ years relevant experience (PhD may waive experience). Experience with quality systems, CAPA, change control, risk management and RCA tools; GMP and regulatory audit familiarity preferred.
Deviation Management system, Change Control, CAPA, document management system, Risk Management, RCA tools, FDA 21 CFR part 11
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
3w
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Staff Engineer – Process & Cleaning Validation
Zebulon, North Carolina, United States
OnsiteContract
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.
3w
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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.
1mo
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Quality Technical and Validation Manager
Zebulon, North Carolina, United States
HybridFull Time
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.
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
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