2w
Save
Mark Applied
Hide
Principal Computer System Validation Specialist
Westborough, Massachusetts, United States
$105k-$150k/yr HybridFull Time
5+ YOEBachelor's degree, 5–8 years computer system validation in pharma/biotech, deep knowledge of GxP/GAMP 5/21 CFR Part 11/Annex 11, experience validating LIMS/MES/QMS/ERP/OSI PI/Empower/SAP/LabWare, strong technical writing and project management.
LIMS, MES, QMS, ERP, OSI PI, Empower, SAP, LabWare, GAMP 5, 21 CFR Part 11, EU Annex 11
1mo
Save
Mark Applied
Hide
Computer System Validation (CSV) Engineer
Piscataway, New Jersey, United States
OnsiteFull Time
5+ YOEPlan, author, and execute CSV validation across regulated systems; ensure compliance with 21 CFR Part 11, EMA/GxP; collaborate across IT, QA, Lab, and Manufacturing.
Caliber LIMS, SAP, BMRAM, IQ/OQ/PQ
2mo
Save
Mark Applied
Hide
CSV Lead/ Computer System Validation Lead
Marietta, Pennsylvania, United States
OnsiteFull Time
10+ YOEBS in engineering, 10+ years project/process engineering or production experience, pharmaceutical/GMP experience, Kneat preferred, strong communication and problem-solving, MS Office proficiency.
Kneat, Microsoft Excel, Microsoft Word, Microsoft Project, Microsoft PowerPoint, Microsoft Access
1w
Save
Mark Applied
Hide
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
Save
Mark Applied
Hide
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
2mo
Save
Mark Applied
Hide
Computer System Validation Lead / Program Manager
Columbus, Ohio, United States
$85k-$120k/yr RemoteFull Time
3+ YOE3+ years CSV experience; Bachelor’s in Engineering/Sciences; regulatory knowledge (21 CFR, ISO, ICH); experience with enterprise apps validation.
SAP, eTMF, CTMS, LIMS, QMS, DCS
3mo
Save
Mark Applied
Hide
Computer Systems Validation Specialist
St. Louis, Missouri, United States
OnsiteFull Time
5+ YOE5+ years of Computer System Validation in GMP/pharma settings; experienced with MES, LIMS, SCADA/PLC, ERP; strong knowledge of GAMP5, 21 CFR Part 11, EU Annex 11; able to lead validation lifecycle and audit readiness.
MES, LIMS, SCADA/PLC, ERP, GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+
2mo
Save
Mark Applied
Hide
Computer Systems Validation Engineer
Cleveland, Ohio, United States
$80k-$100k/yr HybridFull Time
3+ YOE3–5+ years CSV in biotech/pharma; Bachelor's in Life Sciences/Computer Science/Engineering; knowledge of FDA regulations, GAMP 5, data integrity; experience validating GxP systems; strong communication.
LIMS, QMS, ERP, CTMS, EDC, GxP, SaaS, MES, SCADA
3mo
Save
Mark Applied
Hide
Associate Director, QA Computer System Validation
South San Francisco or Radnor
$185k-$215k/yr HybridFull Time
10+ YOEOver 10 years in quality assurance/CSV with GxP; experience with CSV/CSA leadership; familiar with Veeva Vault eQMS, EMA/FDA, data integrity, and regulatory inspections.
Veeva Vault eQMS, Veeva eTMF, SAS, TraceLink, Oracle Fusion
5d
Save
Mark Applied
Hide
System Validation Engineer
San Jose, California, United States
$100k-$113k/yr OnsiteFull Time
2+ YOEBachelor's in computer/electrical engineering, 2+ years experience in AI implementations, hardware testing, and data analysis; Linux and strong software skills; strong communication.
Linux, Grok, Gemini, ChatGPT, Claude, Cursor, Microsoft Excel, Excel Analysis ToolPak
3w
Save
Mark Applied
Hide
Computer Systems Validation Engineer
Portsmouth, New Hampshire, United States
OnsiteFull Time
5+ YOEBachelor's degree required (CS/engineering/sciences preferred); 5+ years CSV experience; 2+ years with controls/automation, MES or Distributed Systems; biotech/pharma/medical device experience; CAPA/deviation and project experience desired.
DeltaV, Manufacturing Execution Systems (MES), GAMP
1w
Save
Mark Applied
Hide
Validation Consultant – Computer System Validation (CSV/CSA)
United States
RemoteFull Time
10+ YOE10+ years CSV/CSA experience for life sciences, deep knowledge of cGxP/GAMP5/21 CFR Part 11/EU Annex 11/ALCOA+, toolkit design, release impact analysis, and audit-ready documentation.
QAD Adaptive ERP, QAD EQMS, NetSuite, ETQ, ISS-Group, Eagle RF
5d
Save
Mark Applied
Hide
System Test and Validation Lead
United States
$95k-$145k/yr OnsiteFull Time
6+ YOEBachelor's degree plus 6+ years in computer system validation for life sciences; experience with GxP validation (IQ/OQ/PQ), GAMP 5, 21 CFR Part 11, EU Annex 11, CAPA, inspection readiness, and AI/ML system validation; travel ~10%.
Veeva, ServiceNow, Salesforce
1mo
Save
Mark Applied
Hide
Engineer II, Computer Systems Validation
Greenville, North Carolina, United States
OnsiteFull Time
2+ YOE2 years validation/CSV in GMP environment; bachelor's in engineering; onsite in Greenville, NC; knowledge of IQ/OQ/PQ; cGMP compliance; familiarity with PLC/SCADA/DCS systems.
PLC, SCADA, DCS, DeltaV, Allen-Bradley, IQ/OQ/PQ
2mo
Save
Mark Applied
Hide
System validation Engineer (Wearables / Embedded HW & FW)
Sunnyvale, California, United States
$100k-$125k/yr OnsiteFull Time
3+ YOEBachelor's in Electrical Engineering, Electronics, Computer Science, or related; 3-5+ years hardware/software validation; battery systems, test automation; Android/iOS testing.
Python, JIRA, ADB, RTOS, Android, iOS, Power analyzers, Oscilloscopes, Data acquisition systems, Environmental chambers
1mo
Save
Mark Applied
Hide
Lead Computer Systems Validation (CSV) Engineer (W)
The Woodlands, Texas, United States
OnsiteFull Time
6+ YOEBachelor's in engineering/computer science/life sciences, 6+ years in regulated biopharma/GMP environment, CSV and data integrity expertise (21 CFR Part 11, EU Annex 11), risk-based validation, Smartsheet and Excel experience, mentorship and cross-functional collaboration skills.
Smartsheet, Microsoft Excel
3w
Save
Mark Applied
Hide
System Verification and Validation Engineer
Foster City, California, United States
$175k-$239k/yr HybridFull Time
5+ YOEBS in Electrical/Computer/Systems Engineering, 5+ years V&V experience for safety‑critical systems, HIL and vehicle testing experience, Python proficiency, statistics knowledge, and expertise in safety and diagnostics.
Python, Hardware-in-the-Loop (HIL), ISO 26262, ARP 4754, ARP 4761, IEC 51511
1d
Save
Mark Applied
Hide
Platform / System Debug Validation Engineer
Austin, Texas, United States
$143k-$245k/yr OnsiteFull Time
Experienced in system- and SoC-level HW/FW debug, data center hardware experience, RAS knowledge, ability to root-cause complex GPU/system issues, and lead junior engineers; Bachelors or Masters in electrical or computer engineering required.
pcie, HBM, RAS, SoC, GPU
2w
Save
Mark Applied
Hide
Principal System Validation Engineer (AI Fabric Switches)
San Jose, California, United States
$237k-$250k/yr OnsiteFull Time
12+ YOEBachelor's in Electrical or Computer Engineering required (Master's preferred), ≥12 years experience with SoC/silicon for server/storage/networking, hands-on validation/debug of high-speed protocols, Python automation, and lab equipment experience.
PCIe, CXL, NVMe, Ethernet, NVLink, x86, ARM, Python, C, C++, Cadence Allegro, Altium, UEFI, Linux, COSMOS
2mo
Save
Mark Applied
Hide
Sr/Principle Computer Systems Validation Specialist
Durham, North Carolina, United States
$118k-$184k/yr OnsiteFull Time
8+ YOESenior/Principal level CSV expertise in cGMP, data integrity, 21 CFR Part 11, FDA-regulated manufacturing; 8+ to 15+ years experience; based in NC; GMP compliance knowledge.
Explore Jobs