Search Jobs | Dice.com

2 results (1 new)

Group by company

Computer System Validation (CSV) Consultants(Biotech Industry exp is must)(Only Visa Independent Candidate/W2)

SumasEdge Corporation

Piscataway, New Jersey • Today

Easy Apply

Contract

Depends on Experience

Computer System Validation (CSV) Consultants

Resourcesys

Piscataway, New Jersey • Today

Easy Apply

Contract

Job Details

Skills

LIMS
Computerized System Validation
DS
Data Integrity
Auditing
Biotechnology
CMMS
PQ
GxP
IQ
Life Sciences
Manufacturing
OQ
Risk Assessment
SAP
SAP MM
SAP PP
SAP QM
Change Control
DirectShow
Documentation
GAMP
Traceability Matrix
URS

Summary

Job Title:- Computer System Validation (CSV) Consultants

Location:- Piscataway, NJ/Chicago, IL (Onsite)

Duration:- Contract to hire

Job Description

Responsibilities

Plan, author, execute, and maintain CSV documentation including Validation Plans (VP), User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications.
Validate systems including LIMS, SAP, CMMS/calibration platforms, and other GxP-regulated applications.
Partner with system owners, Quality, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state through change control and periodic reviews.
Conduct risk assessments and data-integrity assessments aligned with ALCOA+ principles.
Support audits, inspections, CAPAs, deviations, and remediation activitiesrelated to computerized systems.
Apply GAMP 5 and risk-based validation principles throughout the system lifecycle.
Support validation activities involvingCaliber LIMS, SAP QM/MM/PP, BMRAM or comparable CMMS/calibration systems where applicable.

Required Qualifications

5+ years of Computer System Validation experience within a GxP-regulated environment.
Strong, demonstrable CSV experience specifically within Biotechnology/Biotech environments – REQUIRED.
Hands-on experience authoring and executing IQ/OQ/PQ protocols.
Strong working knowledge of 21 CFR Part 11, EU Annex 11, GxP, GAMP 5, and risk-based validation.
Experience validating at least two of the following:

Laboratory instruments
Manufacturing/engineering equipment
LIMS
SAP
CMMS/calibration systems

Experience working cross-functionally withQuality, IT, Laboratory, Manufacturing, and technical SMEs.
Bachelor’s degree in Life Sciences, Engineering, IT, or equivalent relevant life-sciences laboratory experience.
Ability and willingness to work onsite 5 days per week.
Candidates must be interested and eligible for a contract-to-hire opportunity

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: 90859492
Position Id: 9066218
Posted 1 day ago

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Piscataway, New Jersey

•

Today

Job Title:- Computer System Validation (CSV) Consultants Location:- Piscataway, NJ/Chicago, IL (Onsite) Duration:- Contract to hire Job Description Responsibilities Plan, author, execute, and maintain CSV documentation including Validation Plans (VP), User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports. Perform CSV activities for laboratory instruments, engineering/manuf

Easy Apply

Contract

Computer System Validation (CSV) Engineer

Piscataway, New Jersey

•

Today

Title : Computer System Validation (CSV) Engineer Locations: Piscataway, NJ | Chicago, IL Work Arrangement: Onsite Employment Type: Full-Time Experience: 5+ Years of CSV Experience in a GxP-Regulated Environment Job Summary We are seeking an experienced Computer System Validation (CSV) Engineer to support validation activities across a broad portfolio of regulated systems, including laboratory instrumentation, manufacturing and engineering equipment, and enterprise applications. The C

Easy Apply

Full-time, Third Party

Depends on Experience

CSV Consultant(Computer System Validation ? GenAI, Agentic , SAP

Raritan, New Jersey

•

Today

< style="line-height: 1.3em; font-size: 1.2em; margin-bottom: 8px; color: rgb(32, 32, 32); font-family: "Segoe UI", "Lucida Sans Unicode", "Lucida Grande", sans-serif; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: left; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; te

Contract

USD45.0/HOURLY - USD52.0/HOURLY

CSV Lead

Hybrid in Raritan, New Jersey

•

Yesterday

Job Title: CSV Lead Location - Raritan, NJ (Hybrid) W2/C2C Mandatory Skills - LIMS Lab Vantage & CSV Job Summary: Experience in the Pharmaceutical, biotechnology with LIMS Labvantage related System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidances and industry standards (i.e., GAMP) Experience in writing and executing documentation for all as

Easy Apply

Third Party, Contract

55 - 60