9,831 validation jobs at 1,852 companies in Coventry, RI
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Senior Validation Engineer
Framingham, Massachusetts, United States
$152k-$197k/yrOnsiteFull Time
ReplimuneNASDAQ: REPL: Develops oncolytic immunotherapies for cancer treatment.
7+ YOE7+ years validation experience in cGMP environment, bachelor’s in scientific/engineering field (masters preferred), expertise with GMP utilities/equipment, validation lifecycle, technical writing, and regulatory compliance.
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.
RoslinCT: Contract manufacturing for advanced cell and gene therapies.
8+ YOE8+ years QA experience in GMP environments, 3+ years validation QA, knowledge of GAMP, cGMP, ICH, 21 CFR Part 11/Annex 11, ability to review validation deliverables and support investigations.
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.
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
0+ YOEDegree or equivalent experience in engineering/life sciences; knowledge of cGMP, FDA, ISO and GAMP5; IQ/OQ/PQ execution; strong technical writing, data analysis, and project management; valid driver’s license and up to 25% travel.
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.
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.
6+ YOEBachelor's in a science discipline with 6+ years related experience (or Master's with 3+ years). Knowledge of ICH/GMP process validation, technical writing, statistics, and Microsoft Office; Minitab/SPC preferred.
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.
Sr. Engineer, Commissioning, Qualification, and Validation
Norwood, Massachusetts, United States
$131k-$209k/yrHybridFull Time
ModernaNasdaq: MRNA: Develops and manufactures messenger RNA medicines and vaccines.
5+ YOEBachelor’s degree in pharmaceutical or life science and 5+ years cGMP validation/CQV experience including IQ/OQ/PQ, change controls, deviations, CAPA, and validation execution.
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: 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
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
CharterCARE Health of Rhode Island: Regional healthcare network providing hospital and medical services.
CCS required; extensive ICD-9/ICD-10 and CPT coding experience in acute care and validation experience; AS or BS in Health Information field; strong communication and auditing skills.