Genetix Biotherapeutics: Developing and commercializing curative gene therapies for rare diseases.
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
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.
Veeva Vault RIM Test & Validation Lead (CSV / QEA)
Boston, Massachusetts, United States
$71k-$113k/yrHybridFull Time
CognizantNASDAQ: CTSH: Provides IT consulting and technology services to global enterprises.
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 Test & Validation Lead (CSV / QEA)
Boston, Massachusetts, United States
$71k-$113k/yrHybridFull Time
CognizantNasdaq: CTSH: Provides global information technology and business process outsourcing services.
8+ YOE3–5 years Veeva Vault RIM configuration; 8+ years CSV experience; Life Sciences with GxP; Regulatory Affairs and eCTD knowledge; regulatory submission experience.
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
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.
Verista: Provides compliance, automation, and validation services to life sciences.
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.
Alegeus: Provides technology platforms for managing healthcare benefit accounts.
End-user technical support experience, SQL and CSV file handling, BS in technical discipline or equivalent, strong analytical and communication skills.
NTT DATA: Global provider of IT and business consulting services.
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
OpenExchange: Secure video platforms and managed services for financial communications.
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.
Tata Consultancy ServicesNational Stock Exchange of India: TCS: Global provider of IT services, consulting, and business solutions.
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.
Veeva SystemsNYSE: VEEV: Cloud-based software solutions for the global life sciences industry.
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).
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/yrHybridFull Time
EY: Global firm providing audit, tax, and professional consulting services.
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.
Associate Director, Lab Computing and Facilities Technology
Cambridge or Norton
$172k-$233k/yrHybridFull Time
Alnylam PharmaceuticalsNASDAQ: ALNY: Develops RNAi therapeutics to treat rare and common diseases.
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+
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.
Candel TherapeuticsNASDAQ: CADL: Develops viral immunotherapies for the treatment of cancer.
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.
InsuletNasdaq: PODD: Manufactures wearable tubeless insulin pumps for diabetes care.
5+ YOEExperience in medical device manufacturing, automation, validation (IQ/OQ/PQ/CSV), root cause investigation, Lean/Six Sigma, solidworks and statistical tools, and ability to work in cGMP cleanroom environments.
Microsoft Office, Microsoft Excel, Minitab, JMP, SolidWorks