2w
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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.
4d
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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.
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.
1w
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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
2d
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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
1mo
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Validation Manager, Quality Assurance
Watertown, Massachusetts, United States
$107k-$161k/yr HybridFull Time
3+ YOEBachelor's in engineering/chemistry/life sciences/pharmacy; 3+ years GMP validation/QA in biotech or pharma aseptic manufacturing; experience with equipment, utilities, CSV, commissioning, and global GMP/regulatory requirements.
radio-HPLC, GC, gamma spectroscopy, dose calibrators, LIMS, EMS, BMS, Manufacturing Execution System, synthesis/automation software, asset management system, 21 CFR Part 11, EU GMP Annex 11, GAMP 5, ALCOA+
4d
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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.
1w
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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
2w
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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
3mo
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Senior Commissioning/Validation Specialist
Cleveland or New York or Albany or Boston or Rochester or Vestal or Hauppauge
$107k-$203k/yr OnsiteFull Time
10+ YOEBachelor's in engineering; 10+ years related experience; strong organizational, negotiation and interpersonal skills; willing to travel; meet schedules and quality
2w
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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
3w
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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.
3d
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Pharma IT Testing & Validation Delivery Lead
Boston, Massachusetts, United States
$110k-$130k/yr OnsiteFull Time
8+ YOE8+ years IT and QA experience, 5+ years supporting pharma/life sciences, experience leading global testing delivery, knowledge of GxP/CSV/CSA and 21 CFR Part 11, stakeholder management, test strategy and data validation.
Artificial Intelligence, CSV
1mo
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Advisor - Antibody Developability Validation & Benchmarking
Boston or Indianapolis or San Francisco
$167k-$266k/yr OnsiteFull Time
4+ YOEPhD plus ≥4 years post-PhD antibody discovery/developability experience. Experience with antibody assays, numbering tools, ML validation protocols, federated learning, statistical study design, and reproducible MLOps.
ANARCI, AC-SINS, SMAC, CIC, nanoDSF, DSF, BVP-ELISA, Heparin RT, PSR, HIC, SAbDab, OAS, TAP, FLAb, Jain et al. clinical-stage antibody panel, NVIDIA FLARE, Flower, OpenFL, PySyft, AlphaFold-Multimer, IgFold, ABodyBuilder, ESM-2, AbLang, IgBERT, AntiBERTa, PyTorch, Hugging Face, scikit-learn, RDKit, MLflow, Weights & Biases, Kabat, Chothia, IMGT
1mo
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Director of Regulatory Compliance & Validation Strategy
Cambridge, Massachusetts, United States
$160k-$190k/yr OnsiteFull Time
10+ YOE10+ years managing quality systems in regulated environments (medical devices preferred); deep hands-on experience with ISO 9001, ISO 17025, 21 CFR Part 820/11, CSV, IQ/OQ/PQ; audit leadership and customer validation experience.
Computer Systems Validation (CSV), IQ/OQ/PQ, GD&T, industrial CT, CMM, statistical process control, MSA, CAPA, NCMR, PPAP, FAI
1w
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Computer System Validation - Senior Consultant - Life Sciences
New York or Boston or Chicago or Hoboken or McLean or Pittsburgh or Philadelphia or Washington
$94k-$155k/yr HybridFull Time
3+ YOEBachelor's degree in a technical field and 3+ years life sciences validation experience; strong CSV, SDLC/Agile, GxP/regulatory and risk-based validation knowledge.
Veeva Vaults, MES, ERP, LIMS, Validation Lifecycle Management Systems, SDLC, Agile
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