1mo
Save
Mark Applied
Hide
CSV Engineer
Columbus, Ohio, United States
OnsiteContract
3+ YOEBachelor's in engineering/CS/life sciences, 3–6 years CSV or automation systems experience in regulated industries, knowledge of cGMP/GAMP 5 and 21 CFR Part 11, validation documentation experience, U.S. work authorization required.
MES/OMS, GAMP 5, 21 CFR Part 11
2mo
Save
Mark Applied
Hide
IT CSV Engineer
Redmond, Washington, United States
$115k-$135k/yr HybridFull Time
5+ YOELead validation for CSV in GMP/GxP, ensure regulatory compliance, collaborate on CSV projects, develop validation docs, manage testing per FDA CSA/GAMP5, risk management, data integrity.
GxP validation, CSA, Data Integrity, IQ, OQ, PQ, Validation Master Plan, Data migration plans
1mo
Save
Mark Applied
Hide
CSV Specialist II
Durham, North Carolina, United States
OnsiteFull Time
3+ YOEBachelor's in engineering/IT, 3+ years CSV experience in pharma/biotech, GAMP and 21 CFR Part 11 expertise, validation documentation and testing, and proficiency with Microsoft Excel and electronic document management systems.
GAMP, 21 CFR Part 11, Microsoft Office, Microsoft Excel, electronic document management systems
3d
Save
Mark Applied
Hide
Senior CSV Engineer
United States
OnsiteContract
3+ YOE3+ years validating lab equipment and instruments, producing CSV documentation, executing test scripts, knowledge of 21CFR Part 11 and data integrity, change control, strong written and verbal communication.
1mo
Save
Mark Applied
Hide
CSV Engineer III
West Chester, Ohio, United States
$80k-$118k/yr OnsiteFull Time
Independent automation and computer system validation (CSV) experience, knowledge of GAMP 5, 21 CFR Part 11, ALCOA+ data integrity, ability to read P&IDs, and strong technical communication and problem-solving skills.
GAMP 5, 21 CFR Part 11, ALCOA+, PLC, SCADA, DCS, Rockwell/Allen-Bradley, Siemens, Emerson DeltaV, data historian, SDLC, validation lifecycle management (VLM)
3mo
Save
Mark Applied
Hide
CSV Engineer I
Columbus, Ohio, United States
HybridFull Time
2+ YOE2+ years CSV in GxP; knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11; Veeva Vault QMS/BMRAM validation; strong technical writing; onsite Columbus 3-4 days/week.
Veeva Vault QMS, BMRAM, Laboratory instruments (HPLC/UHPLC/PCR), NetSuite, Metasys, Waters, Agilent Chromeleon, Empower
3w
Save
Mark Applied
Hide
CSV Engineering Lead
New York City, New York, United States
HybridFull Time
5+ YOE5+ years in computer system validation within medical devices/pharma/biotech, deep CSV lifecycle knowledge, familiarity with FDA CSA, strong risk management skills, experience with validation in regulated environments, comfortable using AI, excellent communication, and ability to work independently in a distributed team.
Azure DevOps, Python, PowerShell, LIMS, electronic lab notebooks (ELN), CI/CD, Computer Software Assurance (CSA), ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 11, EU GMP, MDR, GAMP 5
2mo
Save
Mark Applied
Hide
IT CSV Engineer
Redmond, Washington, United States
$115k-$135k/yr HybridFull Time
5+ YOE5+ years in GxP CSV validation; strong knowledge of FDA CSA, 21 CFR Part 11, Annex 11, GAMP5; data integrity focus; cross-functional collaboration.
GxP CSV validation tools, Documentation tools
2mo
Save
Mark Applied
Hide
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
3mo
Save
Mark Applied
Hide
CSV ENGINEER
Not Specified, Not Specified, United States
OnsiteFull Time
5+ YOEBachelor's degree in Computer Science or Engineering; 5-8 years in a regulated environment; 1-2 years PM; knowledge of FDA/European regulations and GAMP; ERP/EQMS familiarity; validation deliverables; experience with validated systems.
ERP, EQMS, Quality systems software, Calibration software, Building management software
4d
Save
Mark Applied
Hide
Sr. CSV/CQV Specialist
Raritan, New Jersey, United States
$111k-$145k/yr OnsiteFull Time
8+ YOEBachelor's degree in science or engineering,8+ years relevant CSV/CQV and GMP experience,expertise with 21 CFR Part 11/EU Annex 11,data integrity,validation,TrackWise/CMMS/Maximo and Microsoft Office proficiency.
SAP, MES, BAS, EDS, TrackWise, CMMS, Maximo, Microsoft Outlook, Microsoft Excel, Microsoft Word, Microsoft PowerPoint
1mo
Save
Mark Applied
Hide
CSV Specialist II (Newark, DE, US, 19711)
Newark, Delaware, United States
$95k-$105k/yr OnsiteFull Time
5+ YOEBachelor's in CS/IT/Engineering/Life Sciences (or equivalent), 5+ years CSV experience in regulated industry, knowledge of GxP/21 CFR Part 11/Annex 11, ability to prepare validation deliverables, and strong organizational and analytical skills.
4w
Save
Mark Applied
Hide
CSV Engineer - Automation Engineering
Lebanon or Carmel or Indianapolis
$66k-$172k/yr OnsiteFull Time
2+ YOEB.S. in Engineering required, 2+ years in FDA-regulated environments, experience with computer system validation for automation systems, knowledge of GxP/GMP and data integrity, and authorized to work in the U.S.
DCS, SCADA, BMS, MES, Historian, Building Management System, Data Historian, Automated Storage and Retrieval System, QMS, Kneat, ALM, Valgenesis, DeltaV, Rockwell, Syncade, LabVantage, OSI PI, Site Historian, GAMP, 21 CFR Part 11
2mo
Save
Mark Applied
Hide
CSV Specialist (Remote Position)
United States
RemoteFull Time
5+ YOEExperience in pharmaceutical manufacturing, sterile packaging, C&Q activities, cGMP, 5+ years validation in pharmaceutical facilities, digital validation tools, English/Spanish bilingual, MS Office proficiency.
MS Office, ALM, Quality Management System
1w
Save
Mark Applied
Hide
Senior Specialist Quality Assurance, CSV
United States or Europe or New York City
$101k-$123k/yr RemoteFull Time
7+ YOE7+ years pharma/biotech experience, 5+ years CSV lifecycle experience, bachelor\u0002s in life science, strong knowledge of 21 CFR Part 11/GAMP 5/GDPR, SaaS validation, and AI/ML system assessment.
GAMP 5, 21 CFR Part 11, GDPR, SDLC, Computer System Validation (CSV), Computer System Assurance (CSA), AI/ML, SaaS, PaaS
1mo
Save
Mark Applied
Hide
6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2
Durham or Fishers
$65k-$91k/yr OnsiteFull Time
5+ YOEBachelor's degree required; 5+ years CSV experience in GMP pharmaceutical/biotech; PLC/HMI and historian validation experience; PAT instrument integration experience preferred; ability to author CSV deliverables and perform data integrity assessments; must be local to RTP and work onsite 100%.
PLC, HMI, PAT, NIR, NTP, Historian
1mo
Save
Mark Applied
Hide
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
3w
Save
Mark Applied
Hide
Manager, CSV Cell Therapy
Summit, New Jersey, United States
$107k-$129k/yr OnsiteFull Time
5+ YOEBS or equivalent, 5+ years in FDA-regulated industry, strong cGxP and 21 CFR Part 11 knowledge, SDLC experience, equipment qualification/validation expertise, technical writing and Microsoft Office proficiency.
MS Windows, Microsoft Word, Microsoft Excel, Microsoft Visio, Microsoft Outlook
3mo
Save
Mark Applied
Hide
Director, Automation Engineering & CSV
Bridgeton, Missouri, United States
OnsiteFull Time
10+ YOESenior-level leadership overseeing multi-site pharmaceutical automation programs; 10+ years in pharma automation; strong validation and lifecycle management experience.
PLC, SCADA, HMI, MES, GAMP 5, IQ/OQ/PQ
1w
Save
Mark Applied
Hide
CSV - Quality Systems Specialist
Wilson, North Carolina, United States
$85k-$127k/yr OnsiteFull Time
3+ YOEBachelor's degree and 3–5 years CSV experience in regulated industries; hands-on validation lifecycle experience; knowledge of 21 CFR Part 11, GAMP 5, data integrity; audit and inspection support; strong collaboration and communication skills.
LIMS, PAS-X, SAP
Explore Jobs