302 validation engineer jobs at 178 companies in Coventry, RI
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Validation Engineer III
Boston or Boxborough
OnsiteFull Time
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.
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.
Principal BioPharma Manufacturing Validation Engineer
Westborough, Massachusetts, United States
$119k-$170k/yrOnsiteFull Time
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.
Process Validation Engineer (Medical Device) #2323
Westborough, Massachusetts, United States
OnsiteContract, Full Time
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.
TrelleborgNasdaq Stockholm: TREL B: Manufactures polymer-based solutions for sealing, damping, and protecting applications.
3+ YOEBachelor's degree in Engineering or Computer Science and 3+ years in CSV/software validation within regulated environments; knowledge of FDA/ISO requirements; experience with ERP, QMS, LIMS; strong documentation and communication skills.
GAMP 5, 21 CFR Part 11, EU Annex 11, ISO 13485, ALCOA+, Microsoft Office, Project, Statistical Software
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.
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.
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
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
Director: Engineering, Facilities and Validation (Canton, MA, US, 02021)
Canton, Massachusetts, United States
$196k-$237k/yrOnsiteFull Time
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.
Senior Quality Engineer, Computer System Validation (CSV)
Northbridge or Watertown
$142k-$179k/yrHybridFull Time
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
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
AbbVieNYSE: ABBV: Develops and sells innovative pharmaceutical and biopharmaceutical medicines.
5+ YOEBachelor's in chemical or mechanical engineering; MS/PhD preferred; 5+ years in pharmaceutical aseptic process design, equipment selection and operation; experience with upstream/downstream biologics processing.
Project Lead - Validation (Supervisor) (Fall River, Massachusetts, United States)
Fall River, Massachusetts, United States
$76k-$103k/yrOnsiteFull Time
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
Garg Consulting Services: Provides professional multidisciplinary engineering services for transportation infrastructure projects.
6+ YOEBachelor's in Civil Engineering or Construction Management (or NICET II/III), minimum 6 years construction office engineering with field inspection, CTDOT experience preferred, strong organization/communication, valid driver's license.
KLANASDAQ: KLAC: Provides process control and yield management for semiconductor manufacturing.
5+ YOELead applications and systems engineer for capacitance gauging; system integration, validation, troubleshooting, calibration, documentation, and cross-functional collaboration.
Weston & Sampson: Provides engineering and environmental services for public infrastructure.
2+ YOE2+ years engineering experience (2–5 preferred), Bachelor's in Civil/Environmental Engineering, AutoCAD/Civil 3D/GIS/Revit experience, PE preferred, valid driver’s license, strong communication and project management skills.