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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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.
1mo
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Validation Engineer III
Durham, North Carolina, United States
$99k-$183k/yr OnsiteFull Time
5+ YOEBachelor's degree in engineering or science with 5+ years pharmaceutical validation experience; strong GMP knowledge, validation lifecycle experience, environmental mapping, Kaye Validator experience, ASTM E2500 and GAMP 5 familiarity, and strong technical writing.
Kaye Validator, ASTM E2500, GAMP 5
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
2d
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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)
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.
3w
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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
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
1d
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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.
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
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 experience; lead projects; experience with temperature mapping, calibration, CMMS and Tableau; familiarity with regulatory requirements (FDA) and cGMP preferred.
Tableau, CMMS, P&ID, Thermal Data Logger
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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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
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
1w
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6460 - Senior CQV Engineer / Senior Validation Engineer
Durham, North Carolina, United States
$70k-$110k/yr OnsiteFull Time
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
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.
2d
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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
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
2d
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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
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.
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