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.
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
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.
RTXNYSE: RTX: Provides advanced aerospace and defense systems and services.
2+ YOEBachelor's in STEM plus 2+ years troubleshooting electrical/mechanical issues; ability to obtain/maintain U.S. government security clearance (Secret required); experience with RF and test equipment and test software preferred.
Power Meters, Oscilloscopes, Spectrum Analyzers, Network Analyzers, TestStand, LabView
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.
2+ YOEBachelor's in science/engineering required, minimum 2 years biopharma operations experience, knowledge of cGMP, aseptic processing/validation and audits, strong communication and documentation skills.
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.
Mechatronics Test Engineer, Hardware Verification and Validation
North Reading, Massachusetts, United States
$137k-$186k/yrOnsiteFull Time
AmazonNASDAQ: AMZN: Global online retail and cloud computing technology provider.
Develop and execute test programs and verification plans for robotic hardware, design and operate test benches, analyze test data, and produce test reports.