563 validation engineer jobs at 273 companies in Barrington, RI
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Sr Engineer, Validation
Canton, Massachusetts, United States
$129k-$156k/yrOnsiteFull Time
Emergent BioSolutionsNYSE: EBS: Develops and manufactures vaccines and therapeutics for health threats.
8+ YOEBachelor's in engineering, chemistry, microbiology, or related field and/or 8 years of industrial validation experience. Requires validation expertise, GMP knowledge, technical writing, and systems experience.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Kaye AVS, SPC, DMAIC, CIP, SIP, PFDs, P&IDs
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.
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.
AmgenNASDAQ: AMGN: Develops and manufactures biotechnology medicines for serious diseases.
2+ YOERequires high school diploma/GED with 8 years, associate's with 6 years, bachelor's with 2 years, or master's degree, plus manufacturing and operations experience. GMP biotechnology, validation, technical writing, and regulatory knowledge 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.
AppleNASDAQ: AAPL: Designs and sells consumer electronics, software, and online services.
Perform lab characterization and validation of analog and mixed-signal embedded circuits and collaborate with cross-functional teams to support mobile SoC launches.
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%.
Syner-G BioPharma Group: Provides CMC and regulatory services for life sciences companies.
3+ YOEBachelor's in life science, 3+ years biotech/pharma/medical device validation experience, knowledge of FDA cGMP, FMEA, CSV, protocol generation and IQ/OQ/PQ reporting, strong written/verbal communication.
FDA cGMP, FMEA, Computerized System Validation (CSV), Piping and Instrumentation Diagram (P&ID)
Celldex TherapeuticsNASDAQ: CLDX: Developing antibody-based immunotherapies for inflammatory and autoimmune diseases.
8+ YOERequires 8+ years in cGMP/GLP industries, a technical bachelor's degree or equivalent, and validation experience with regulated computer, network, ERP, Veeva, laboratory, and production systems.
21 CFR Part 11, EU GMP, EU GMP Annex 11, GAMP, ERP, Veeva, AI
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.
3+ YOEBachelor's degree in electrical engineering, 3+ years relevant experience in analog/mixed-signal verification or post-silicon validation, proficiency with behavioral modeling and lab measurements.
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.
Verista: Provides compliance, automation, and validation services to life sciences.
4+ YOEBachelor's degree or equivalent, 4+ years CQV/validation experience in GMP environments, strong technical writing and communication, ability to mentor, Microsoft Office proficiency.
Lead Computer Systems Validation Engineer I (Clinical & R&D)
Waltham, Massachusetts, United States
$110k-$126k/yrHybridFull Time
AlkermesNASDAQ: ALKS: Develops medicines for psychiatric and neurological disorders.
7+ YOEBachelor’s degree in computer science, life sciences, engineering, or related field with 9+ years in digital quality; master’s with 7+ years considered. Requires GxP, CSV, quality systems, compliance, data integrity, and team leadership experience.
MerckXETRA: MRK: A science and technology providing healthcare, life science, and electronics solutions.
1+ YOEBachelor's degree in engineering, chemistry, biology, or life science; 1+ year of pharmaceutical lab experience; validation protocol, cGMP, analytical, communication, and customer-facing skills.
Washington or Massachusetts or Indiana or North Carolina or New Jersey or New Hampshire or New Mexico or New York or Pennsylvania or South Carolina or South Dakota or Texas or Kentucky or Mississippi or Seattle or Boston or Tokyo
$225k-$250k/yrRemoteFull Time
Aurion Biotech: Developing regenerative cell therapies to restore vision for patients.
12+ YOE5+ MgmtBachelor's, master's, or doctorate in science or engineering; 12+ years in MSAT, process development, or external manufacturing; 5+ years managing people; cell therapy, GMP validation, comparability, and regulatory submission experience.
Associate Director, Process Validation and Tech Transfers
Lexington, Massachusetts, United States
$170k-$230k/yrHybridFull Time
Wave Life SciencesNasdaq: WVE: Designing and developing RNA medicines for genetic diseases.
8+ YOEPhD/MS in biochemistry/chemistry/engineering preferred; 8+ years bio-pharma manufacturing in cGMP; oligonucleotide PPQ experience; strong validation and tech transfer skills.
Massachusetts Bay Transportation Authority: Operates public transportation services in the Greater Boston area.
3+ YOEBachelor's degree in engineering and three years of industrial engineering experience; requires analytical skills, planning or project management experience, software proficiency, and a valid driver's license.