865 validation engineer jobs at 353 companies in Revere, MA
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Validation Engineer II
Framingham, Massachusetts, United States
$137k-$177k/yrOnsiteFull Time
ReplimuneNASDAQ: REPL: Develops oncolytic immunotherapies for cancer treatment.
5+ YOEBachelors in scientific/engineering field required (MSc preferred); 5+ years validation/engineering experience with cGMP utilities and equipment; strong technical writing and communication skills.
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
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.
MerckXETRA: MRK: A science and technology providing healthcare, life science, and electronics solutions.
4+ YOEBachelor's (or Master's) in engineering/science with 3–4+ years in product/process development or validation, experience with IQ/OQ/PQ, FMEA/risk analysis, protocol/report authoring, and statistical analysis.
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.
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%.
AMETEKNYSE: AME: Manufacturer of electronic instruments and electromechanical devices.
5+ YOEBS in Mechanical Engineering or Mechanical Engineering Technology, minimum 5 years progressive engineering experience, product design and testing experience, AutoCAD and SolidWorks experience, strong problem-solving and stress analysis knowledge.
Verista: Provides compliance, automation, and validation services to life sciences.
5+ YOEBachelor’s degree in engineering and approximately five or more years of commissioning, qualification, process engineering, or validation experience in biotechnology or pharmaceutical manufacturing. Requires bioprocess equipment, FAT/SAT, IQ/OQ, GMP, troubleshooting, and technical-writing experience.
Alcami: Provides contract drug development and manufacturing services.
5+ YOE5+ years direct validation experience, BA/BS preferred, experience with autoclave, temperature mapping, sterilization and GMP/GLP systems, calibration aptitude, strong technical writing and communication skills, up to 80% travel.
InsuletNasdaq: PODD: Manufactures wearable tubeless insulin pumps for diabetes care.
2+ YOEBachelor's degree with 2+ years of relevant experience or Master's with 1 year; experience in medical device manufacturing, process validation, data analysis; ISO 13485/QMS familiarity; FDA guidelines knowledge.
LonzaSIX Swiss Exchange: LONN: Manufactures medicines and provides development services for healthcare companies.
5+ YOEBachelor's degree required (CS/engineering/sciences preferred); 5+ years CSV experience; 2+ years with controls/automation, MES or Distributed Systems; biotech/pharma/medical device experience; CAPA/deviation and project experience desired.
DeltaV, Manufacturing Execution Systems (MES), GAMP
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.
Merck KGaA, Darmstadt, GermanyFrankfurt Stock Exchange: MRK: A science and technology in healthcare, life sciences, and electronics.
4+ YOEBachelor’s degree plus 4+ years or master’s degree plus 3+ years in engineering or science and process/product validation; 2+ years in FMEA and 3+ years in validation required.
Skyworks SolutionsNASDAQ: SWKS: Designs and manufactures analog and mixed-signal semiconductor solutions.
Current MS or PhD student in electrical engineering, computer science, or related field with automation or data analysis experience, scripting knowledge, RF fundamentals, and strong analytical and communication skills.
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.