1mo
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Validation Engineer
Chelsea, Massachusetts, United States
$89k-$110k/yr OnsiteFull Time
3+ YOEBachelor's degree required, 3+ years GMP manufacturing/validation experience, strong knowledge of FDA/EMA regulations (GAMP, ICH, USP, 21 CFR), experience with IQ/OQ/PQ and validation documentation.
GAMP, GEA Niro SD1, GEA Niro SD4, GEA Niro SD7
1w
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Validation Engineer
Danvers, Massachusetts, United States
$100k-$120k/yr OnsiteFull Time
8+ YOEPrepare TMV protocols and reports, perform validation, apply Gage R&R, select measurement tools, create test procedures and validation plans, and produce ISO/regulatory audit-ready documentation for medical devices.
Gage R&R, vernier/calipers, micrometers
3mo
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Validation Engineer III
Boston or Boxborough
OnsiteFull Time
5+ YOEFive+ years in validation/engineering in regulated env; cGMP/pharma/biotech/medical device exp; SME in validation disciplines; strong writing and project management; proficient with GMP utilities and equipment.
1mo
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CQV/Validation Engineer
Holbrook, Massachusetts, United States
$33-$43/hr OnsiteFull Time
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.
AutoCAD
1w
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Validation Engineer 2
Bedford, Massachusetts, United States
$85k-$127k/yr OnsiteFull Time
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.
Minitab
3mo
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Validation Engineer II (Billerica, US)
Billerica, Massachusetts, United States
$104k-$116k/yr OnsiteFull Time
4+ YOEBachelor’s in science or engineering; 4+ years of related experience; knowledge of cGMP and ISO standards; equipment validation/qualification experience.
1w
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Validation Engineer
Waltham, Massachusetts, United States
OnsiteFull Time
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.
1mo
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Principal BioPharma Manufacturing Validation Engineer
Westborough, Massachusetts, United States
$119k-$170k/yr OnsiteFull Time
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.
3d
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Senior Engineer, Process Validation
United States or Boston or Dallas or Chicago or Sunnyvale or Houston or Indianapolis or Raleigh
$100k-$130k/yr RemoteFull Time
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%.
pFMEA, DOE
5d
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Test & Validation Engineer II
Andover, Massachusetts, United States
$69k-$131k/yr OnsiteFull Time
2+ YOEBachelor's in STEM and ~2 years test engineering experience; ability to obtain U.S. security clearance; experience with RF test equipment and test procedures; proficiency with TestStand and LabVIEW preferred.
TestStand, LabVIEW, oscilloscope, spectrum analyzer, network analyzer, power meter
1w
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Mechanical Design & Validation Engineer
Wilmington, Massachusetts, United States
$100k-$140k/yr OnsiteFull Time
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.
AutoCAD, SolidWorks
1mo
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Process Validation Engineer (Medical Device) #2323
Westborough, Massachusetts, United States
OnsiteContract, Full Time
7+ YOEBachelor's in Engineering, 7+ years medical device process engineering, experience with process validation (IQ/OQ/PQ), DOE, FMEA, CAPA/NCR ownership, FDA/ISO 13485 knowledge, strong analytical and communication skills.
2mo
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Software Validation Engineer
Northborough, Massachusetts, United States
$95k-$105k/yr OnsiteFull Time
3+ YOE3+ years CSV/software validation in regulated environment; Bachelor's in Engineering/CS; strong regulatory knowledge.
JIRA, Microsoft Office, Project, Statistical Software
1w
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Sr. Validation Engineer
Pepperell, Massachusetts, United States
$43-$53/hr OnsiteFull Time
5+ YOE5+ years direct validation experience; develop/execute IQ/OQ/PQ protocols for environmental chambers, autoclaves, SIP, and GMP equipment; calibration and temperature mapping experience; strong technical writing and communication; willingness to travel up to 80%.
2mo
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Software Validation Engineer
Northborough, Massachusetts, United States
$95k-$105k/yr HybridFull Time
3+ YOEBachelor's degree in Engineering or Computer Science and 3+ years in CSV/software validation within regulated environments; knowledge of FDA/ISO requirements; experience with ERP, QMS, LIMS; strong documentation and communication skills.
GAMP 5, 21 CFR Part 11, EU Annex 11, ISO 13485, ALCOA+, Microsoft Office, Project, Statistical Software
1mo
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NPI and Validation Engineer
Acton, Massachusetts, United States
OnsiteFull Time
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.
DMAIC, Six Sigma, DOE, QMS ISO 13485
1w
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6444 - Lead CQV Engineer / Lead Validation Engineer
Devens, Massachusetts, United States
$88k-$147k/yr OnsiteFull Time
10+ YOEBachelor's degree required; 10+ years CQV/aseptic filling/isolator experience; strong technical writing, vendor coordination, sterile boundary and risk management; ValGenesis experience a plus.
ValGenesis
1mo
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Senior Engineer II, Quality Validation
Braintree, Massachusetts, United States
$94k-$130k/yr OnsiteFull Time
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.
1w
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Hardware & Silicon Validation Senior Staff Engineer
Westborough or Santa Clara
$143k-$212k/yr OnsiteFull Time
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.
oscilloscope, logic analyzer, protocol analyzer, FPGA, Python, Perl, Shell, C, C++, Linux
1w
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Senior Robotics Verification & Validation (V&V) Engineer
Boston or Raynham
$92k-$148k/yr HybridFull Time
3+ YOEBachelor's or master's in engineering,3+ years V&V in medical devices,knowledge of embedded/firmware/testing,requirements tools and test automation,strong technical writing and systems engineering skills.
DOORS, Jama, Polarion, Python, LabVIEW, MATLAB, SAP Product Lifecycle Management
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