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CSV Lead

Nityo Infotech Corporation

Hybrid in Durham, North Carolina • Yesterday

Easy Apply

Contract

Depends on Experience

Senior Veeva Technical Architect

TATA Consultancy Services Limited

Remote or Hopewell Township, New Jersey • 26d ago

Easy Apply

Full-time

140,000 - 180,000

Senior Data Engineer

Machinify

Remote • Today

Full-time

USD 180,000.00 - 220,000.00 per year

Job Details

Skills

csv
DELTA

Summary

Role - CSV Lead

Location- Durham, NC (Hybrid, must visit site 2-3 days a week)

Job Description-

Must have worked in CSV in Manufacturing automation systems like DELTA V,PI Historian, PLC, LAB Automation Systems(any one pf the systems or all).

Primary: CSV (Computer System Validation) Compliance

Secondary: SDLC / CSA / Validation Governance / Quality Compliance.

Hands-on experience supporting validation and compliance activities for computerized manufacturing systems in a regulated pharmaceutical environment.

Familiar with Kneat,SNOW,Veeva Systems.

Provide CSV compliance support for Capital and Strategic Projects to ensure continuity of compliance oversight and project delivery.

Develop, review, and approve validation lifecycle deliverables in accordance with GxP requirements, internal SOPs, and regulatory expectations.

Provide compliance guidance to project teams on SDLC, CSA (Computer Software Assurance), qualification, risk-based validation, and change control processes.

Strong experience in Computer System Validation (CSV) within GMP-regulated pharmaceutical/manufacturing environments.

Knowledge of Validation Lifecycle, CSA, SDLC, Qualification (IQ/OQ/PQ), Change Control, CAPA, and Risk Management.

Experience reviewing and approving validation documentation and compliance deliverables.

Familiarity with GxP regulations, Data Integrity, FDA, EMA, and industry compliance requirements.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10200946b
Position Id: 9106818
Posted 1 day ago

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Contact the job poster

Vipin Kumar

Recruitment Manager @ Nityo Infotech Corporation

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Durham, North Carolina

•

Today

We are looking for Lead Computer System Validation Engineer for our client in Durham, NCJob Title: Lead Computer System Validation Engineer Job Location: Durham, NC Job Type: Contract Pay Range: $50.00hr - $55.00hr Job Overview: The Lead Computer System Validation (CSV) Specialist provides hands-on validation and compliance support for computerized manufacturing systems within a regulated pharmaceutical environment. This role focuses primarily on CSV compliance, SDLC, CSA, validation governance,

Easy Apply

Third Party, Contract

Depends on Experience

Senior Engineer, Validation

Raleigh, North Carolina

•

Today

TITLE: Senior Engineer, Validation WHO WE ARE Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline of p

Full-time

USD 88,000.00 - 105,000.00 per year

Sr Engineer 1, Process Validation

Holly Springs, North Carolina

•

Today

Position Overview The Senior Engineer or Scientist of Process Validation ensures that manufacturing processes meet the validation and regulatory requirements to ensure the process is robust and reproducible under normal operating conditions. This role involves designing, executing, and documenting process validation protocols for equipment, systems, and manufacturing processes. Additionally, this role works closely with cross-functional teams to ensure that processes are consistently producing

Full-time

CSV and Validation Engineer

New Jersey

•

Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument s

Full-time