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CSV Engineer

Katalyst Healthcares and Lifesciences

San Francisco, California • Today

Full-time

CSV Engineer

Katalyst Healthcares and Lifesciences

Redwood City, California • Today

Full-time

Tableau Engineer

Accylerate

Remote • Today

Easy Apply

Contract

70 - 75

Tableau Engineer

Analytics Solutions

Remote • Today

Easy Apply

Contract

$50 - $90

Tableau Engineer

Sun Technologies,Inc.

Remote • Today

Easy Apply

Contract

60 - 80

Job Details

Skills

Collaboration
Quality Assurance
Testing
Training
Regulatory Compliance
Auditing
GxP
Element Management System
EMS
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
Element Management System
EMS
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
Assist 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.
Ability 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: 5e8235bccb9c83b85bef86aed3764e0d
Posted 13 days ago

Fitment

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Similar Jobs

CSV Engineer

New Jersey

•

Today

Job Description: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer

Full-time

Software Foundation Data & Compute Senior SQA Engineer

San Jose, California

•

Today

Introduction to the job The senior lead SQA engineer is responsible for leading validation activities for shared Data & Compute platform capabilities across multiple products. The role focuses on validating new functionality and platform enhancements in areas such as Data Pipelines, Infrastructure Services, MLOps, UI Frameworks, Recipe Management, and related platform components. The position owns progression testing strategy, execution, and quality assessment for new developments, ensuring fu

Full-time

USD 140,250.00 - 210,375.00 per year

Sr. Systems Validation Engineer

San Jose, California

•

Today

Job Req ID: 29412 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

Sr. Systems Validation Engineer 1 1

San Jose, California

•

Today

Job Req ID: 29416 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

Job Details

Skills

Collaboration
Quality Assurance
Testing
Training
Regulatory Compliance
Auditing
GxP
Element Management System
EMS
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
Element Management System
EMS
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
Assist 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.
Ability 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: 5e8235bccb9c83b85bef86aed3764e0d
Posted 13 days 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.

Similar Jobs

CSV Engineer

New Jersey

•

Today

Full-time

Software Foundation Data & Compute Senior SQA Engineer

San Jose, California

•

Today

Full-time

USD 140,250.00 - 210,375.00 per year

Sr. Systems Validation Engineer

San Jose, California

•

Today

Full-time

USD 130,000.00 - 165,000.00 per year

Sr. Systems Validation Engineer 1 1

San Jose, California

•

Today

Full-time