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CSV Engineer

Katalyst Healthcares and Lifesciences

San Francisco, California • 12d ago

Full-time

SAP Computer System Validation (CSV)

ClifyX

Foster City, California • 9d ago

Easy Apply

Contract

Depends on Experience

Computerized System Validation (CSV) Consultant @ Remote

BURGEON IT SERVICES LLC

Remote • Yesterday

Easy Apply

Contract

Depends on Experience

Sr. Computer Systems Validation Engineer

CooperCompanies

Remote or Trumbull, Connecticut • Today

Full-time

Data Engineer III

SelectQuote Insurance Services

Remote • Today

Full-time

USD 115,000.00 per year

Data Engineer II

SelectQuote Insurance Services

Remote • Today

Full-time

USD 95,000.00 per year

Senior Data Engineer

Machinify

Remote • Today

Full-time

USD 180,000.00 - 220,000.00 per year

Remote Senior Data Engineer

Kforce Technology Staffing

Remote or Carlsbad, California • Today

Full-time

$140,000 - $170,000 annually

CSV Engineer

Katalyst Healthcares and Lifesciences

Redwood City, California • 12d ago

Full-time

Job Details

Skills

Collaboration
Quality Assurance
Testing
Training
Regulatory Compliance
Auditing
GxP
EMS
Element Management System
GMP
Manufacturing
Software Development
Software Development Methodology
Functional Requirements
FRS
Risk Assessment
Regulatory Affairs
Data Integrity
IQ
OQ
PQ
Reporting
Computer Science
GAMP
Enterprise Resource Planning
LIMS
MES
Documentation
Technical Writing
Analytical Skill
Problem Solving
Conflict Resolution
Communication
Cloud Computing
Verification And Validation
Computerized System Validation
Biotechnology
Research

Collaboration
Quality Assurance
Testing
Training
Regulatory Compliance
Auditing
GxP
EMS
Element Management System
GMP
Manufacturing
Software Development
Software Development Methodology
Functional Requirements
FRS
Risk Assessment
Regulatory Affairs
Data Integrity
IQ
OQ
PQ
Reporting
Computer Science
GAMP
Enterprise Resource Planning
LIMS
MES
Documentation
Technical Writing
Analytical Skill
Problem Solving
Conflict Resolution
Communication
Cloud Computing
Verification And Validation
Computerized System Validation
Biotechnology
Research

Summary

Roles & Responsibilities:

Develop and implement validation strategies for computer systems and software applications.
Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports.
Perform risk assessments to identify potential issues and ensure compliance with regulatory requirements.
Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems.
Conduct validation testing and review test results to ensure systems meet specified requirements.
Provide training and support to staff on validation processes and procedures.
Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance.
Participate in audits and inspections by regulatory agencies.
Execute Validation Project Plans (VPPs) for manufacturing GxP systems such as, Client, EMS, & PCS.
Support the execution of VPPs to qualify systems for GMP Manufacturing Equipment in accordance with Software Development Lifecycle (SDLC) procedures as per GAMP5 industry standards
ssist site Automation groups in configuring I/O and executing CSV protocol requirements.
Independently perform CSV lifecycle deliverables, including but not limited to, Functional Requirements Specification (FRS), Configuration Specification (CS), Electronic Records and Electronic Signatures (ERES), Risk Assessment (RA), Data Integrity (DI) Assessment, IQ/OQ/PQ, & Summary Report

Requirements:

Bachelor's degree in Computer Science, Engineering, or a related field.
Minimum of 2-5 years of experience in computer system validation or a related field.
Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5).
Experience with validation of various types of systems, including ERP, LIMS, and MES.
Excellent documentation and technical writing skills.
Strong analytical and problem-solving abilities.
bility to work independently and as part of a team.
Excellent communication and interpersonal skills.
Preferred: Certification in Computer System Validation or related areas.
Experience with cloud-based systems and software validation, experience with Blue Mountain RAM.
3+ years of work experience with Computer System Validation.
3+ years of Biotechnology Research experience.

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: 91116760
Position Id: e36ade6b0f84695a3536398146f4dc93
Posted 30+ days ago

Fitment

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Similar Jobs

Sr. Computer Systems Validation Analyst

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12d ago

Summary : We are seeking a Senior Computer Systems Validation (CSV) Analyst with strong experience in GxP-regulated pharmaceutical/life sciences environments. The candidate will be responsible for planning, leading, and executing validation activities for SCADA, Rockwell FactoryTalk, PLCs, and Ignition process control systems. The role requires hands-on expertise in GAMP 5, 21 CFR Part 11, EU Annex 11, validation lifecycle documentation, risk assessments, change controls, and qualification prot

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Easy Apply

Contract

35 - 40

Sr. Systems Validation Engineer

San Jose, California

•

Today

Job Req ID: 30237 About Supermicro: Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and IoT/Embedded customers worldwide. We are the #5 fastest growing company among the Silicon Valley Top 50 technology firms. Our unprecedented global expansion has provided us with the opportunity to offer a large number of new positions to the technology community. We seek talented, pass

Full-time

USD 130,000.00 - 165,000.00 per year

Job Details

Skills

Collaboration
Quality Assurance
Testing
Training
Regulatory Compliance
Auditing
GxP
EMS
Element Management System
GMP
Manufacturing
Software Development
Software Development Methodology
Functional Requirements
FRS
Risk Assessment
Regulatory Affairs
Data Integrity
IQ
OQ
PQ
Reporting
Computer Science
GAMP
Enterprise Resource Planning
LIMS
MES
Documentation
Technical Writing
Analytical Skill
Problem Solving
Conflict Resolution
Communication
Cloud Computing
Verification And Validation
Computerized System Validation
Biotechnology
Research

Collaboration
Quality Assurance
Testing
Training
Regulatory Compliance
Auditing
GxP
EMS
Element Management System
GMP
Manufacturing
Software Development
Software Development Methodology
Functional Requirements
FRS
Risk Assessment
Regulatory Affairs
Data Integrity
IQ
OQ
PQ
Reporting
Computer Science
GAMP
Enterprise Resource Planning
LIMS
MES
Documentation
Technical Writing
Analytical Skill
Problem Solving
Conflict Resolution
Communication
Cloud Computing
Verification And Validation
Computerized System Validation
Biotechnology
Research

Summary

Roles & Responsibilities:

Develop and implement validation strategies for computer systems and software applications.
Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports.
Perform risk assessments to identify potential issues and ensure compliance with regulatory requirements.
Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems.
Conduct validation testing and review test results to ensure systems meet specified requirements.
Provide training and support to staff on validation processes and procedures.
Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance.
Participate in audits and inspections by regulatory agencies.
Execute Validation Project Plans (VPPs) for manufacturing GxP systems such as, Client, EMS, & PCS.
Support the execution of VPPs to qualify systems for GMP Manufacturing Equipment in accordance with Software Development Lifecycle (SDLC) procedures as per GAMP5 industry standards
ssist site Automation groups in configuring I/O and executing CSV protocol requirements.
Independently perform CSV lifecycle deliverables, including but not limited to, Functional Requirements Specification (FRS), Configuration Specification (CS), Electronic Records and Electronic Signatures (ERES), Risk Assessment (RA), Data Integrity (DI) Assessment, IQ/OQ/PQ, & Summary Report

Requirements:

Bachelor's degree in Computer Science, Engineering, or a related field.
Minimum of 2-5 years of experience in computer system validation or a related field.
Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5).
Experience with validation of various types of systems, including ERP, LIMS, and MES.
Excellent documentation and technical writing skills.
Strong analytical and problem-solving abilities.
bility to work independently and as part of a team.
Excellent communication and interpersonal skills.
Preferred: Certification in Computer System Validation or related areas.
Experience with cloud-based systems and software validation, experience with Blue Mountain RAM.
3+ years of work experience with Computer System Validation.
3+ years of Biotechnology Research experience.

Dice Id: 91116760
Position Id: e36ade6b0f84695a3536398146f4dc93
Posted 30+ days ago

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Create job alert

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Similar Jobs

Sr. Computer Systems Validation Analyst

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•

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Software Quality Validation Engineer (Medical Devices) - Only On W2

Pleasanton, California

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Sr. Systems Validation Engineer

San Jose, California

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