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
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
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
5d
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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
2w
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Master Technician Validation and Testing (68295)
Raleigh, North Carolina, United States
$69k-$101k/yr OnsiteFull Time
3+ YOEAssociate degree in electronics or related field, 3+ years lab/test experience, hands-on electronics troubleshooting, proficiency with test equipment, EM automation scripting, strong communication and organizational skills.
Robot Framework, Python, Selenium, OPAL-RT, JIRA, Zephyr
2mo
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Sr/Principle Computer Systems Validation Specialist
Durham, North Carolina, United States
$118k-$184k/yr OnsiteFull Time
8+ YOESenior/Principal level CSV expertise in cGMP, data integrity, 21 CFR Part 11, FDA-regulated manufacturing; 8+ to 15+ years experience; based in NC; GMP compliance knowledge.
1mo
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C&Q Validation Manager / Senior Manager - Project Farma
Greenville or Huntsville or Raleigh
FieldFull Time
7+ YOE4+ Mgmt7-13 years life sciences/CQV experience, 4+ years managing teams, Bachelor's or Master's in life science/engineering or equivalent experience, business development experience, willingness to travel, valid driver's license required.