6,153 validation jobs at 1,465 companies in Elon, NC
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Validation Lead
Morrisville or Durham
$126k-$234k/yrOnsiteFull Time
NovartisNew York Stock Exchange: NVS: Develops and manufactures innovative prescription medicines for patients.
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
MedPharm: Developing and manufacturing topical and transdermal pharmaceutical products.
Develop and maintain cleaning validation programs, approve procedures and deliverables, support regulatory inspections, train personnel, and ensure compliance with regulatory and business standards.
CSLASX: CSL: Global biotechnology developing and manufacturing protein-based therapies and vaccines.
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.
OXBLondon Stock Exchange: OXB: Provides viral vector development and manufacturing services for therapies.
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.
Valspec: Provides system validation and lifecycle services for life sciences companies.
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.
FujifilmTokyo Stock Exchange: 4901: Diversified manufacturer of healthcare, imaging, and semiconductor material products.
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
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/yrOnsiteFull Time
Siemens HealthineersFrankfurt Stock Exchange: SHL: Provides medical imaging and diagnostic solutions to healthcare providers.
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%.
FujifilmTokyo Stock Exchange: 4901: Providing medical imaging, healthcare solutions, and photographic technology products.
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.
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
Sr/Principle Computer Systems Validation Specialist
Durham, North Carolina, United States
$118k-$184k/yrOnsiteFull Time
KBI Biopharma: Contract development and manufacturing for biopharmaceutical companies.
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.
FujifilmTokyo Stock Exchange: 4901: Provider of diagnostic imaging and healthcare technology solutions.
0+ YOEBachelor’s in Life Sciences/Engineering with 2 years experience OR Master’s with no experience; 1-3 years GMP experience; validation and quality oversight in FDA-regulated facilities; knowledge of GAMP5, data integrity, and 21 CFR requirements.
ASTM E2500, Smartsheets, Trackwise, Veeva, Kneat, GAMP5, 21 CFR Part 820, 21 CFR Part 11
ZoetisNYSE: ZTS: Produces medicines and vaccines for livestock and pets.
5+ YOEBS or MS in a relevant scientific field,5+ years laboratory/animal research experience,animal handling and device integration experience,GLP/GCP exposure preferred,strong communication and critical thinking.
Research Triangle Park, North Carolina, United States
HybridFull Time
Fujifilm SonositeTokyo Stock Exchange: 4901: Develops portable ultrasound systems for point-of-care medical diagnostics.
12+ YOE12+ years in biopharma manufacturing or industrial tech; 3+ years as Product Owner/Manager or Business Analyst; strong knowledge of MES/Synchronization with DeltaV; Agile leadership; experience with regulated GxP environments.
Altoona or Charlotte or Columbus or Dayton or Dublin or Lewisburg or Eller or Gumtree or Hagerstown or Harrisburg or Harrisonburg or Hazle Township or Hazleton or Limestoneville or Milton or Rockingham or Trotwood or Waughtown or Winston-Salem or Youngstown
$25-$26/hrFieldFull Time
Watsontown Trucking Company: Family-owned providing nationwide freight and logistics services.
2+ YOEValid Class A CDL, minimum 2 years verifiable CDL-A experience, valid DOT medical card, must pass DOT drug screen.
Amedisys: Provides home-based nursing, hospice, and palliative care services.
1+ YOE1+ year RN clinical experience; valid RN license for assigned states; current CPR; valid driver’s license with reliable transportation and liability insurance.