317 csv engineer jobs at 203 companies in United States
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Senior CSV Engineer
Indianapolis, Indiana, United States
OnsiteFull Time
Performance Validation: Provides commissioning, qualification, and validation services for life sciences.
5+ YOE5+ years in regulated manufacturing automation with CSV/C&Q experience, degree in an engineering or technical discipline, knowledge of GAMP, EU Annex 11, data integrity, and strong communication skills.
PM Group: International engineering, architecture, and project management services firm.
0+ YOEBachelor’s degree in a technical field, 0–3 years of CSV, laboratory, IT, automation, quality control, or pharmaceutical manufacturing experience, GxP knowledge, technical writing, and Microsoft Office proficiency.
LIMS, CDS, ELN, SDMS, Microsoft Word, Microsoft Excel
Resilience: Provides contract development and manufacturing services for complex medicines.
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.
Stallergenes Greer: Develops and markets allergen immunotherapy treatments for allergies.
3+ YOEBachelor's degree in computer science, engineering, or related field; 3+ years in regulated industries; project management experience; knowledge of FDA, European, and GAMP validation requirements.
Microsoft Office, ERP, PLC, SCADA, DCS, EQMS, quality systems software, calibration software, building management software
CognizantNasdaq: CTSH: Provides global information technology and business process outsourcing services.
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.
EvotecFrankfurt Stock Exchange: EVT: Accelerates drug discovery and biologics development for pharmaceutical partners.
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
PM Group: International project delivery firm for high-tech industrial facilities.
8+ YOEBachelor's degree in a technical discipline and 8+ years of GxP computer system validation experience. Requires senior CSV protocol execution, laboratory systems expertise, cGMP, GAMP 5, data integrity, and regulatory compliance knowledge.
LIMS, GxP, IQ, OQ, PQ, GAMP 5, 21 CFR Part 11, EU Annex 11, IT/OT
Eli Lilly and CompanyNYSE: LLY: Researches and manufactures medicines for human health.
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
EvotecFrankfurt Stock Exchange: EVT: Provides drug discovery and development services through global research alliances.
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.
Verista: Provides compliance, automation, and validation services to life sciences.
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%.
Legend BiotechNASDAQ: LEGN: Develops cell therapies for the treatment of cancer.
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
Kashiv BioSciences: Develops biosimilars and drug delivery systems for medicine improvement.
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.
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.
CognizantNASDAQ: CTSH: Provides IT consulting and technology services to global enterprises.
3+ YOEMinimum 3 years validating and supporting lab equipment, strong written and oral communication, knowledge of 21CFR Part 11 and data integrity desirable, experience in regulated/pharmaceutical environments preferred.
Lead Computer Systems Validation (CSV) Engineer (W)
The Woodlands, Texas, United States
OnsiteFull Time
Cellipont Bioservices: Contract development and manufacturing organization for cell therapies.
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.
Johnson & JohnsonNYSE: JNJ: Develops and manufactures pharmaceutical drugs and medical devices.
8+ YOEBS degree or equivalent in engineering, science, or related field; 8+ years in manufacturing and 2+ years in pharmaceutical execution systems, automation, or IT. Requires CSV, GMP, automation, MES, and leadership expertise.
Emerson DeltaV, OSI PI, Siemens PLCs, MES, Werum PAS-X, DeltaV Batch Control, Industrial Automation Networks, ERP, Quality Systems, Data Warehouses, CDL, ISA S95, ISA S88, 21 CFR Part 11, EU GMP Annex 11, OSI PI Historian, Werum MES, GAMP 5, Artificial Intelligence (AI), Machine Learning (ML), Quality Assurance (QA), Robotic Automation, Smart Systems, Workflow Automation
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
8+ YOEBachelor's degree or equivalent in engineering, science, or related field; 8+ years in regulated manufacturing; 2+ years in execution systems, automation, or IT; expertise in CSV, GMP, automation, MES, and change control.
Emerson DeltaV, OSI Pi, Siemens PLCs, MES, Werum PAS-X, DeltaV Batch Control, Industrial Automation Networks, ERP, Quality Systems, Data Warehouses, CDL, ISA S95, ISA S88, OSI PI Historian, Werum MES, GAMP 5, Artificial Intelligence (AI), Machine Learning (ML), Robotic Automation
Quantifind: AI-driven platform for financial risk and fraud detection.
3+ YOE3+ years customer-facing technical/support/consulting experience; experience implementing SaaS in enterprise environments; familiarity with APIs, SQL, Jira, GitHub, CSV/JSON; BS/MS in CS/math/engineering or equivalent.