6,548 validation jobs at 1,661 companies in Fuquay-Varina, 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
NovartisSIX Swiss Exchange, NYSE: NOVN, NVS: A global pharmaceutical focused on developing and manufacturing medicines and therapies.
8+ YOE5+ MgmtBachelor's in chemistry/pharmacy/chemical engineering/pharmaceutical technology,8 years manufacturing experience,5 years process validation leadership,expertise in process/cleaning validation,quality systems,applied statistics and global regulations.
Performance Validation: Provides commissioning, qualification, and validation services for life sciences.
1+ YOEBS/BA degree with 1-2 years in pharmaceutical or regulated industry validation; degrees in Biomedical, Chemical, or Mechanical Engineering preferred.
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.
Barry-Wehmiller: Manufactures industrial machinery for packaging and paper processing.
2+ YOEBachelor's degree in bioengineering, biomedical, chemical engineering, or related technical field; strong technical writing and communication skills; experience with validation projects and willingness to travel.
Microsoft Office, Microsoft Project, AutoCAD, FAT, SAT, IQ, OQ, QMS, ICH Q1, CFR 21 Part 211, CFR 21 Part 820, ICH Q8, ICH Q9, ICH Q10
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.
PSC Biotech: Provides regulatory, quality, and engineering consulting services for life sciences.
7+ YOEBachelor's degree in a technical discipline and 7+ years of validation, commissioning, qualification, or quality engineering experience in FDA-regulated industries; KNEAT and CSV experience required.
KNEAT, Computer System Validation (CSV), GAMP 5, 21 CFR Part 11
CSLASX: CSL: Global biotechnology producing plasma-derived and recombinant therapies.
5+ YOERequires 5+ years of commissioning, qualification, or validation experience and a bachelor's degree in engineering, technical, or science field. DeltaV qualification experience required; pharmaceutical manufacturing experience preferred.
DeltaV, Data Historian, Building Automation Systems, Manufacturing Execution Systems
CSLASX: CSL: Global biotechnology developing and manufacturing protein-based therapies and vaccines.
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
Syner-G BioPharma Group: Provides CMC and regulatory services for life sciences companies.
7+ YOEBachelor's degree in life science, engineering, or related technical field; 7–11 years in biotech, pharmaceutical, or medical device industries; expertise in GMP validation, CSV, risk assessment, protocols, audits, and remediation.
Valspec: Provides system validation and lifecycle services for life sciences companies.
Bachelor's degree in engineering or a related technical discipline; process validation and PPQ experience in biopharmaceutical or pharmaceutical manufacturing; technical writing, qualification coordination, GMP, process validation, and FMEA knowledge.
Novo NordiskNYSE: NVO: Develops and manufactures medicines for diabetes and chronic diseases.
7+ YOEBachelor's degree in engineering, computer science, or a related technical field, or equivalent experience; 7+ years of pharmaceutical validation or quality experience; knowledge of 21 CFR Part 11, GAMP5, ISO, FDA, and ICH guidance.
United States or Boston or Dallas or Chicago or Sunnyvale or Houston or Indianapolis or Raleigh
$100k-$130k/yrRemoteFull Time
DanaherNYSE: DHR: Develops scientific instruments and diagnostic tools for healthcare markets.
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%.
LTIMindtreeNational Stock Exchange of India: LTIM: Global technology consulting and digital solutions.
5+ YOEBachelor's degree in electrical or computer engineering, 5+ years with D2D and SERDES platforms, Python, test equipment, SERDES calibration, signal integrity, and high-speed protocols.
Fujifilm SonositeTokyo Stock Exchange: 4901: Develops portable ultrasound systems for point-of-care medical diagnostics.
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.
Eupry: Automated temperature monitoring and compliance services for healthcare industries.
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
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%.
KBI Biopharma: Contract development and manufacturing for biopharmaceutical companies.
5+ YOEBachelor's or master's degree in engineering or information technology, 5–7 years of industry experience, lab equipment and IT computer validation experience, biotech cGMP knowledge, and project management skills.
Web applications, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, email
PM Group: International engineering, architecture, and project management services firm.
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.
PM Group: International project delivery firm for high-tech industrial facilities.
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.