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Somerville, New Jersey

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2d ago

Role Title: Shop floor CSV/CSA Lead/Engineer Duration: 6+ Months Location: Somerville, NJ Job Description - Worked on validation and compliance activities for shop-floor automation systems like PLC, SCADA, and MES in GMP/GxP environments. Prepared and executed test plans, validation documents, risk assessments, and supported system changes, audits, and issue resolution. Coordinated with IT, quality, engineering, and manufacturing teams to ensure systems operated securely, accurately, and a

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Full-time, Third Party

Depends on Experience

Computer System Validation (CSV) only W2 (NO CTC OR C2H)

Raritan, New Jersey

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2d ago

CSV/CSA Lead/Engineer Raritan, NJ onsite 6 MOnths Job Description - Shop floor CSV/CSA Lead/Engineer Lead and execute validation deliverables across the lifecycle: risk assessment, validation planning, requirements traceability, test strategy, test execution, deviation management, and final reporting/release. Apply a risk-based approach (e.g., GxP impact, patient/product risk, data integrity) to define validation scope and testing depth. Author/review validation documentation such as: o Comp

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Contract

Depends on Experience

CSV Validation/ Clinical

Hybrid in Independence Township, New Jersey

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Yesterday

CSV Validation/ ClinicalIntroduction:As a CSV Validation/ Clinical specialist, you will be responsible for defining validation strategies for computerized systems and platforms used in the GxP space. Your role will involve creating validation deliverables, participating in user review meetings, conducting risk assessments, and effectively communicating validation activities to project teams and stakeholders. Responsibilities:Define validation strategy for computerized systems and platforms in Gx

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Full-time

Depends on Experience

Sr. Computerized System Validation (CSV) Manager

Remote

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8d ago

We are Looking for a Senior Computerized System Validation (CSV) Manager with CRO industry experience. This a full-time permanent hire position with our client. In this role you can work fully remote (anywhere in USA). In this role as a Senior Computerized System Validation (CSV) Manager, you will lead the transformation of CSV practices within the organization. In this role as a Senior Computerized System Validation (CSV) Manager you will ensure validation processes are risk-based, efficient, a

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Full-time

Depends on Experience

CSV Engineer

Raritan, New Jersey

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Today

Roles & Responsibilities Lead end-to-end CSV activities (inventory assessment remediation disposition) Support business separation for large GxP systems Define & implement risk-based validation strategies Review & approve test plans, UAT scripts, validation documents Ensure compliance with regulatory & quality standards Provide guidance, escalation & leadership to validation teams Collaborate with global & remote teams Education & Experience : 7-10 years in CSV / Validation roles Experience in P

Full-time

CSV Lead

Hybrid in Raritan, New Jersey

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14d ago

Role - CSV Lead Location - Raritan, NJ (Hybrid) W2/C2C Mandatory Skills: Validating and guiding team in ERP, Data migration, Cloud migration associated with Divestiture and Separation. Job Details: Must be able to Independently support Business Separation activities for Large global & regional GxP Computerized systems with minimal supervison. Recent experience with Acquisitions/Separations/Divestiture from client a huge plus. Strong CSV Expertise, especially within Acquisition/Divestiture/Sep

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Contract, Third Party

55 - 60

CSV Engineer

New Jersey

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Today

Summary : CSV Validation Engineer is responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role will focus on validating ERP Master Data Governance processes and Data Lake platforms, ensuring compliance with regulatory requirements and data integrity standards. Roles & Responsibilities: Author, review, and execute validation test scripts (IQ/OQ/PQ) for GxP computerized systems Support validation activities for E

Full-time

Computer System Validation Analyst (CSV)

Somerville, New Jersey

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Today

Demonstrated experience in Computer System ValidationProvide quality guidance from a CSV perspective based on the J&J CSV Framework and SDLC process Strong verbal and written communication skills.Preferred tools knowledge and experience: JIRA, qTest, ServiceNow, XRAY and Change Record reviewExperience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.

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Contract

Depends on Experience

CSV Engineer

South Plainfield, New Jersey

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Today

Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments). Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans. Providing leadership, oversight, and training related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentati

Full-time

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