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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.
1w
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Senior Validation Engineer
Framingham, Massachusetts, United States
$152k-$197k/yr OnsiteFull Time
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.
2w
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Principal – QA Validation
Hopkinton, Massachusetts, United States
$130k-$160k/yr OnsiteFull Time
8+ YOE8+ years QA experience in GMP environments, 3+ years validation QA, knowledge of GAMP, cGMP, ICH, 21 CFR Part 11/Annex 11, ability to review validation deliverables and support investigations.
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
3w
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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
2mo
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Qualification & Validation Specialist
Wilmington, Massachusetts, United States
$60k-$100k/yr OnsiteFull Time
3+ YOE3–7 years pharma/biopharma validation experience with DQ/IQ/OQ/PQ, strong FDA cGMP knowledge, protocol and GMP documentation skills, and demonstrated project management (Gantt/milestone tracking).
1w
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Validation Engineer II
Plainville, Massachusetts, United States
$66k-$99k/yr HybridFull Time
0+ YOEDegree or equivalent experience in engineering/life sciences; knowledge of cGMP, FDA, ISO and GAMP5; IQ/OQ/PQ execution; strong technical writing, data analysis, and project management; valid driver’s license and up to 25% travel.
Microsoft Office, GAMP5, IQ/OQ/PQ
2mo
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System Validation Specialist
Boston, Massachusetts, United States
$55k-$75k/yr OnsiteFull Time
Hands-on maintenance and validation of healthcare monitoring equipment; travel within region; strong customer service.
Test meters, Diagnostic tools, Schematics reading tools
1w
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Silicon Validation Engineer
Waltham, Massachusetts, United States
OnsiteFull Time
Perform lab characterization and validation of analog and mixed-signal embedded circuits and collaborate with cross-functional teams to support mobile SoC launches.
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.
3w
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6441 - CSV Engineer / Validation Engineer
Devens, Massachusetts, United States
$70k-$114k/yr OnsiteFull Time
5+ YOEBachelor's degree required; 5+ years GMP document control/validation document management; ValGenesis preferred; Autodesk Forma experience; GDP and electronic records fluency; strong organization and communication.
ValGenesis, Autodesk Forma
3d
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Sr. Manager, System Validation
Bellevue or North Reading
$198k-$268k/yr OnsiteFull Time
10+ YOE5+ Mgmt10+ years planning and delivering software/infrastructure, bachelor's in CS or related, expertise in system verification/validation for electromechanical systems, cloud and programming language experience.
Rust, Java, C, C++, Linux, AWS, Azure
2w
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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
2mo
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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
3w
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Data Validation Risk - Director
New York City or Atlanta or Charlotte or Chicago or Washington or Boston or Florham Park or Dallas or Philadelphia
$155k-$410k/yr OnsiteFull Time
8+ YOEBachelor's degree, at least 8 years' experience, expertise in data validation, analytics, visualization, and client leadership; familiarity with databases, cloud platforms, and ML tools preferred.
Alteryx, Python, Power BI, Tableau, Databricks, MS SQL, AWS, Azure, GCP, SAS
2w
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Senior Engineer/Manager, Process Validation
Bedford, Massachusetts, United States
$140k-$161k/yr HybridFull Time
8+ YOEBachelor's (8+ yrs) or Master's (6+ yrs) in engineering/life sciences, 6–8+ years pharma/biotech process validation experience, CMO collaboration, cGMP/ICH knowledge, DOE/SPC statistical methods.
JMP
3w
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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
1mo
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Process Development Validation Scientist II
Milford, Massachusetts, United States
$90k-$110k/yr OnsiteFull Time
6+ YOEBachelor's in a science discipline with 6+ years related experience (or Master's with 3+ years). Knowledge of ICH/GMP process validation, technical writing, statistics, and Microsoft Office; Minitab/SPC preferred.
Microsoft Office, Minitab, SPC
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.
3w
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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