844 validation engineer jobs at 343 companies in Marlborough, 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.
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%.
RTXNYSE: RTX: RTX provides advanced aerospace and defense systems and services.
2+ YOEBachelor's in STEM, 2+ years test engineering experience, U.S. citizenship and ability to obtain interim DoD Secret clearance, RF/test equipment familiarity, TestStand/LabVIEW exposure, strong troubleshooting and communication skills.
TestStand, LabVIEW, power meter, oscilloscope, spectrum analyzer, network analyzer
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.
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.
10+ YOE5+ MgmtBachelor's in a technical field required; 10+ years systems testing/IV&V experience and 5+ years leadership; experience with EW/RADAR/missile systems, test strategy, formal qualification testing, requirements testability, and government contracting; active Secret clearance and ability to obtain Top Secret/SCI.
Senior Specialist, Associate Aseptic Process Validation Engineer
Devens, Massachusetts, United States
$88k-$106k/yrOnsiteFull Time
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
2+ YOEBachelor\u0019s in science/engineering, 2+ years biopharmaceutical operations experience, knowledge of cGMP and aseptic processing/validation, audit experience, strong written/verbal communication.