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548 validation engineer jobs at 272 companies in Fall River, MA

1mo
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Validation Engineer
Chelsea, Massachusetts, United States
$89k-$110k/yr OnsiteFull Time
Catalent
Catalent: Global provider of drug development and manufacturing solutions.
3+ YOEBachelor's degree required, 3+ years GMP manufacturing/validation experience, strong knowledge of FDA/EMA regulations (GAMP, ICH, USP, 21 CFR), experience with IQ/OQ/PQ and validation documentation.
GAMP, GEA Niro SD1, GEA Niro SD4, GEA Niro SD7
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3mo
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Validation Engineer III
Boston or Boxborough
OnsiteFull Time
Barry-Wehmiller
Barry-Wehmiller: Manufactures industrial machinery for packaging and paper processing.
5+ YOEFive+ years in validation/engineering in regulated env; cGMP/pharma/biotech/medical device exp; SME in validation disciplines; strong writing and project management; proficient with GMP utilities and equipment.
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CQV/Validation Engineer
Holbrook, Massachusetts, United States
$33-$43/hr OnsiteFull Time
Sebela Pharmaceuticals
Sebela Pharmaceuticals: Developing and commercializing prescription pharmaceutical products.
3+ YOEBachelor's in Engineering or Life Sciences, 3+ years FDA-regulated validation experience; knowledge of equipment/utility/process/cleaning/computerized system validation, cGMP, 21 CFR Part 11 preferred; strong technical writing; AutoCAD preferred.
AutoCAD
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Validation Engineer
Waltham, Massachusetts, United States
OnsiteFull Time
Syner-G BioPharma Group
Syner-G BioPharma Group: Provides CMC and regulatory services for life sciences companies.
4+ YOEBachelor's in life science or engineering, 4–7 years in biotech/pharma/medical device, strong knowledge of FDA cGMP, FMEA, CSV, and hands-on IQ/OQ/PQ validation experience.
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Principal BioPharma Manufacturing Validation Engineer
Westborough, Massachusetts, United States
$119k-$170k/yr OnsiteFull Time
Astellas Pharma
Astellas PharmaTokyo Stock Exchange: 4503: Global developing and manufacturing pharmaceutical therapies for patients.
8+ YOEBS (10+ yrs) or MS (8+ yrs) in engineering or related discipline; extensive GMP biopharma validation experience supporting PPQ, risk-based validation, regulatory filings, data integrity, and mentoring of junior staff.
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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
Danaher
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%.
pFMEA, DOE
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Process Validation Engineer (Medical Device) #2323
Westborough, Massachusetts, United States
OnsiteContract, Full Time
ECI
ECI: Provides regulatory and engineering consulting for life sciences companies.
7+ YOEBachelor's in Engineering, 7+ years medical device process engineering, experience with process validation (IQ/OQ/PQ), DOE, FMEA, CAPA/NCR ownership, FDA/ISO 13485 knowledge, strong analytical and communication skills.
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Senior Engineer II, Quality Validation
Braintree, Massachusetts, United States
$94k-$130k/yr OnsiteFull Time
Integra LifeSciences
Integra LifeSciencesNASDAQ: IART: Manufacturing surgical instruments and regenerative medical technology devices.
8+ YOEBachelor's in engineering or science required; experience requirement varies by degree (BSc+8y, MSc+5y, PhD+3y). Subject-matter expertise in one or more validation areas (equipment, process, packaging, cleaning, utilities, temp mapping); cGMP/QSR/ISO knowledge and project management skills.
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Hardware & Silicon Validation Senior Staff Engineer
Westborough or Santa Clara
$143k-$212k/yr OnsiteFull Time
Marvell
MarvellNASDAQ: MRVL: Designs and develops high-performance semiconductor and infrastructure solutions.
3+ YOEBachelor's (or Master's/PhD) in CS/EE,3+ years (Master's) or 5+ years (Bachelor's) validating SoCs/ASICs, hands-on lab debugging, high-speed interfaces, scripting (Python/Perl/Shell), C/C++, and Linux.
oscilloscope, logic analyzer, protocol analyzer, FPGA, Python, Perl, Shell, C, C++, Linux
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Senior Robotics Verification & Validation (V&V) Engineer
Boston or Raynham
$92k-$148k/yr HybridFull Time
Johnson & Johnson
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
3+ YOEBachelor's or master's in engineering,3+ years V&V in medical devices,knowledge of embedded/firmware/testing,requirements tools and test automation,strong technical writing and systems engineering skills.
DOORS, Jama, Polarion, Python, LabVIEW, MATLAB, SAP Product Lifecycle Management
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Senior Robotics Verification & Validation (V&V) Engineer
Boston or Raynham
$92k-$148k/yr HybridFull Time
Johnson & Johnson
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
3+ YOEBachelor's in engineering,3+ years V&V in medical devices,knowledge of FDA/ISO/IEC standards,requirements management and test automation experience,statistical analysis and technical writing skills.
DOORS, Jama, Polarion, Python, LabVIEW, MATLAB, SAP Product Lifecycle Management
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Silicon Validation Software Engineer- GPU IP Validation and Integration
Waltham, Massachusetts, United States
OnsiteFull Time
Apple
AppleNASDAQ: AAPL: Designs and sells consumer electronics, software, and online services.
Develop graphics validation software and integrate it into system-level test environments; background in graphics, video encoding/processing, file systems, CPU/cache, kernel programming, or embedded systems.
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System Validation Specialist
Boston, Massachusetts, United States
$55k-$75k/yr OnsiteFull Time
Rees Scientific
Rees Scientific: Provides automated environmental monitoring systems for regulated laboratories.
Hands-on maintenance and validation of healthcare monitoring equipment; travel within region; strong customer service.
Test meters, Diagnostic tools, Schematics reading tools
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3mo
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Senior Commissioning/Validation Specialist
Cleveland or New York or Albany or Boston or Rochester or Vestal or Hauppauge
$107k-$203k/yr OnsiteFull Time
Stantec
StantecTSX: STN: Provides professional engineering, architecture, and environmental consulting services.
10+ YOEBachelor's in engineering; 10+ years related experience; strong organizational, negotiation and interpersonal skills; willing to travel; meet schedules and quality
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Director: Engineering, Facilities and Validation (Canton, MA, US, 02021)
Canton, Massachusetts, United States
$196k-$237k/yr OnsiteFull Time
Emergent BioSolutions
Emergent BioSolutionsNYSE: EBS: Develops and manufactures vaccines and therapeutics for health threats.
15+ YOE8+ MgmtSenior-level leadership of EFV functions for GMP biotech manufacturing; 15+ years in engineering/facilities/validation; strong GMP/regulatory and capital project experience; PE or similar preferred.
GMP, IQ/OQ/PQ, Capital Planning, Project Management, HVAC, WFI, Validation, Maintenance, Automation
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1mo
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Validation Manager, Quality Assurance
Watertown, Massachusetts, United States
$107k-$161k/yr HybridFull Time
Mariana Oncology
Mariana OncologyNYSE: NVS: Developing precision radioligand therapies for solid tumors.
3+ YOEBachelor's in engineering/chemistry/life sciences/pharmacy; 3+ years GMP validation/QA in biotech or pharma aseptic manufacturing; experience with equipment, utilities, CSV, commissioning, and global GMP/regulatory requirements.
radio-HPLC, GC, gamma spectroscopy, dose calibrators, LIMS, EMS, BMS, Manufacturing Execution System, synthesis/automation software, asset management system, 21 CFR Part 11, EU GMP Annex 11, GAMP 5, ALCOA+
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3w
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Senior Quality Engineer, Computer System Validation (CSV)
Northbridge or Watertown
$142k-$179k/yr HybridFull Time
EyePoint Pharmaceuticals
EyePoint PharmaceuticalsNASDAQ: EYPT: Clinical-stage developing sustained-delivery treatments for retinal diseases.
3+ YOEBachelor's degree and 3+ years GxP computerized system validation experience in pharma/biotech/medical device; knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9/Q10 and FDA CSA; strong documentation, risk management, and project leadership skills.
GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9, ICH Q10, FDA Computer Software Assurance (CSA), RCA, FMEA, VSM, ERP
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1w
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Senior Robotics Verification & Validation (V&V) Engineer
Boston or Raynham
$92k-$148k/yr HybridFull Time
Johnson & Johnson
Johnson & JohnsonNYSE: JNJ: Global healthcare providing pharmaceuticals and medical technologies.
3+ YOEBachelor’s or master’s in engineering,3+ years V&V medical device experience, knowledge of regulatory standards (FDA,ISO),requirements management and test automation tools,statistical analysis and technical writing skills.
DOORS, Jama, Polarion, Python, LabVIEW, MATLAB, SAP Product Lifecycle Management
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2mo
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Computer System Validation Lead / Program Manager
Boston, Massachusetts, United States
$85k-$120k/yr RemoteFull Time
Veeva Systems
Veeva SystemsNYSE: VEEV: Cloud-based software solutions for the global life sciences industry.
3+ YOELead CSV for cloud-based applications; plan/execute validation; ensure regulatory compliance (21 CFR, Annex 11, ICH Q10); coordinate cross-functional teams.
SAP, eTMF, CTMS, QMS, LIMS, GAMP 5
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3mo
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Project Lead - Validation (Supervisor) (Fall River, Massachusetts, United States)
Fall River, Massachusetts, United States
$76k-$103k/yr OnsiteFull Time
Cipla
CiplaNational Stock Exchange of India: CIPLA: Manufactures and sells generic medicines and active pharmaceutical ingredients
5+ YOEBachelor’s degree in engineering; 5+ years pharma/biotech validation project management; experience with sterile manufacturing; PMP certification a plus; SAP; MS Project/Primavera.
MS Project, Primavera, SAP, P&ID, cGMP, FDA-regulatory
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