2mo
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Sr. Manager, Quality CSV
Somerville, Massachusetts, United States
$170k-$180k/yr HybridFull Time
7+ YOE7+ years in industry with 5+ years in CSV within a GxP environment; degree in computer systems/engineering; change control experience; regulatory inspection readiness; Veeva Vaults preferred.
GxP, CSV, GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9, ICH Q10, CSA, Veeva Vaults
1mo
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Assoc Director, BI&T Compliance & CSV
Devens, Massachusetts, United States
$177k-$214k/yr OnsiteFull Time
12+ YOEBachelor's in Engineering/IT/CS, minimum 12 years in pharmaceutical quality/QA/CSV/IT compliance, leadership experience, expertise in 21 CFR and GAMP standards, GMP IT oversight, documentation and regulatory interaction skills.
ServiceNow
2mo
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Associate Director, IT CSV and Compliance
Waltham, Massachusetts, United States
$171k-$235k/yr HybridFull Time
5+ YOE5+ Mgmt5+ years regulated IT, CSV/CSA and GxP, FDA/EU inspections, leadership, strong communication
2mo
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Veeva Vault RIM Test & Validation Lead (CSV / QEA)
Boston, Massachusetts, United States
$71k-$113k/yr HybridFull Time
3+ YOE3–5 years Veeva Vault RIM configuration/support; 8+ years CSV; life sciences with GxP; regulatory affairs knowledge; experience with regulatory submissions.
Veeva Vault RIM, CSV, Regulatory Affairs, eCTD, GxP
2mo
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Veeva Vault RIM Test & Validation Lead (CSV / QEA)
Boston, Massachusetts, United States
$71k-$113k/yr HybridFull Time
8+ YOE3–5 years Veeva Vault RIM configuration; 8+ years CSV experience; Life Sciences with GxP; Regulatory Affairs and eCTD knowledge; regulatory submission experience.
Veeva Vault RIM, CSV, GxP, eCTD
1mo
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Assoc Director, BI&T Compliance & CSV
Devens, Massachusetts, United States
$177k-$214k/yr OnsiteFull Time
12+ YOEBachelor's in Engineering/IT/Computer Science, 12+ years in pharmaceutical quality/CSV/IT compliance, leadership experience, expertise in 21 CFR and GAMP, QA and validation knowledge, strong technical writing and problem-solving skills.
ServiceNow
2w
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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
1mo
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Senior Quality Engineer, Computer System Validation (CSV)
Northbridge or Watertown
$142k-$179k/yr HybridFull Time
3+ YOEBachelor's degree and 3+ years GxP computerized system validation experience in pharma/biotech/medical device; knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9/Q10 and FDA CSA; strong documentation, risk management, and project leadership skills.
GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9, ICH Q10, FDA Computer Software Assurance (CSA), RCA, FMEA, VSM, ERP
2d
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Application Support Engineer
Maitland or Milwaukee or Boston
$44k-$75k/yr HybridFull Time
End-user technical support experience, SQL and CSV file handling, BS in technical discipline or equivalent, strong analytical and communication skills.
SQL, CSV
1w
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Oracle NetSuite Supply Chain / Manufacturing Consultant - REMOTE
Boston, Massachusetts, United States
$107k-$198k/yr OnsiteFull Time
5+ YOE5+ years NetSuite functional experience with full-cycle implementations as functional lead focused on Manufacturing, PO, Order Management, SuiteFlow, CSV data migration; undergraduate degree in supply chain/manufacturing/business/IS required.
NetSuite, NetSuite WMS Lite, SuiteFlow, SuiteScript, SuiteQL, CSV, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
3w
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C&Q Lead (Commissioning - Automated Systems)
Devens or Boston
$146k-$205k/yr OnsiteFull Time
10+ YOEBachelor's degree required; 10+ years GMP/pharmaceutical C&Q experience; strong commissioning, qualification, validation, automation and regulatory knowledge (PLCs, SCADA, MES, CSV, GAMP 5, 21 CFR Part 11).
PLC, SCADA, DCS, MES, CSV, GAMP 5, 21 CFR Part 11, ASTM E2500, Annex 11, Annex 15, FDA, EMA, ICH
1mo
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Senior Engineer II, Automation, INT
Marlborough, Massachusetts, United States
$146k-$234k/yr OnsiteFull Time
9+ YOE9+ years experience in pharmaceutical/biotech automation; Bachelor's in engineering (or equivalent); expertise with DeltaV, PLCs, SCADA, AVEVA PI, OPC/Kepware, RESTful APIs, CSV and regulatory requirements (21 CFR Part 11, Annex 11).
ISA-95, ISA-88, DeltaV, PLCs, SCADA, AVEVA PI, Kepware, OPC servers, SIMCA, RESTful APIs, data lakes, WMS, ERP, HART, Ethernet I/P, CSV, IQ/OQ/PQ
1mo
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Associate Solutions Engineer
Boston or New York City or London or Hong Kong
$55k-$75k/yr RemoteFull Time
0+ YOEBachelor's in Computer Science required; 0–2 years technical experience; Python/scripting, SQL and database familiarity, APIs and JSON/CSV; strong communication and client-facing skills; ability to work flexible hours and be forward deployed.
Python, SQL, JSON, CSV, APIs, Claude, OpenAI, LangChain, LlamaIndex
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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Senior Consultant - Veeva Network MDM
Boston, Massachusetts, United States
$80k-$200k/yr RemoteFull Time
5+ YOE5+ years software consulting experience; 3+ years configuring Veeva Network MDM or similar MDM; strong SQL, ETL, APIs, CSV/FTP skills; bachelor’s degree or equivalent; ability to travel 20–30%; authorized to work in the US (no visa sponsorship).
Veeva Network MDM, Vault CRM, SQL, ETL, APIs, CSV, FTP, Informatica, MuleSoft, Salesforce.com
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
1mo
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Associate Director, Lab Computing and Facilities Technology
Cambridge or Norton
$172k-$233k/yr HybridFull Time
10+ YOEBachelor's in CS/Engineering/Life Sciences (or equiv), 10+ years in lab computing/operational technology in biotech/pharma, CSV/GAMP5 expertise, LIMS/ELN support, and leadership of technical teams.
LIMS, ELN/LES, Computer System Validation (CSV), GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, ALCOA+
1w
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Sr Director, QA- GxP Systems
Needham, Massachusetts, United States
$258k-$280k/yr HybridFull Time
10+ YOEBachelor's in life sciences,10+ years biotech/pharma QA with GxP systems, vendor oversight, CSV, audits, and Part 11 compliance; experience with eQMS/EDMS and regulated clinical workflows.
eQMS, EDMS
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.
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+
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