842 validation engineer jobs at 353 companies in Holden, MA
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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.
DrägerXETRA: DRW3: Manufacturer of medical and safety technology products worldwide.
3+ YOEMaster's in engineering and 3 years of related experience, or bachelor's and 5 years. Requires regulated testing, validation, root cause analysis, hazard mitigation, technical documentation, and ISO 13485 experience.
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.
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.
Merck KGaAFrankfurt Stock Exchange: MRK: Develops pharmaceutical, life science, and electronics technologies.
3+ YOEBachelor's degree plus 4+ years or master's degree plus 3+ years in engineering/science and product or process validation; 2+ years in FMEA/risk analysis and 3+ years in validation required.
Minitab, DOE, FMEA, IQ/OQ/PQ, Good Documentation Practice (GDP), FDA Regulations, USP
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)
RTXNYSE: RTX: Provides advanced aerospace and defense systems and services.
2+ YOEBachelor's degree in STEM and 2+ years of test engineering experience required. U.S. citizenship and ability to obtain a Secret security clearance required.
CORE, TestStand, LabVIEW, RF test equipment, power meters, oscilloscopes, spectrum analyzers, network analyzers
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.
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.
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.