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Computer System Validation Engineer

Remote in Bothell, WA, US • Posted 8 days ago • Updated 2 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

FOCUS
Lifecycle Management
Functional Requirements
Quality Assurance
Manufacturing Engineering
Testing
System Requirements
Manufacturing Operations
Regulatory Compliance
Change Control
Incident Management
Auditing
Life Sciences
Information Technology
Computer Science
Biotechnology
Manufacturing Execution System
MES
Computerized System Validation
URS
Functional Design
Risk Assessment
IQ
OQ
PQ
Traceability Matrix
Standard Operating Procedure
GAMP
Good Manufacturing Practice
GxP
Software Development Methodology
Documentation
GDP
Acceptance Testing
Technical Drafting
Defect Management
Enterprise Resource Planning
SAP
Oracle
Quality Management
Veeva
IT Service Management
ServiceNow
Pharmaceutics
Manufacturing
Technical Writing
Communication
Conflict Resolution
Problem Solving
Collaboration
Management

FOCUS
Lifecycle Management
Functional Requirements
Quality Assurance
Manufacturing Engineering
Testing
System Requirements
Manufacturing Operations
Regulatory Compliance
Change Control
Incident Management
Auditing
Life Sciences
Information Technology
Computer Science
Biotechnology
Manufacturing Execution System
MES
Computerized System Validation
URS
Functional Design
Risk Assessment
IQ
OQ
PQ
Traceability Matrix
Standard Operating Procedure
GAMP
Good Manufacturing Practice
GxP
Software Development Methodology
Documentation
GDP
Acceptance Testing
Technical Drafting
Defect Management
Enterprise Resource Planning
SAP
Oracle
Quality Management
Veeva
IT Service Management
ServiceNow
Pharmaceutics
Manufacturing
Technical Writing
Communication
Conflict Resolution
Problem Solving
Collaboration
Management

Summary

Job Summary:

We are seeking an experienced Computer System Validation (CSV) Engineer/Contractor to lead and execute validation activities for GxP computerized systems, with a strong focus on Manufacturing Execution Systems (MES) in a pharmaceutical or biologics manufacturing environment.
The ideal candidate will have expertise in CSV lifecycle management, GAMP, 21 CFR Part 11, protocol development and execution, and cross-functional collaboration to ensure compliance with regulatory and quality requirements.

Roles & Responsibilities:

Lead and execute Computer System Validation (CSV) activities for GxP computerized systems and applications throughout the validation lifecycle.
Develop, review, execute, and maintain CSV documentation, including Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications, Risk Assessments, IQ, OQ, PQ protocols, Traceability Matrices, Validation Summary Reports, and SOPs.
Support the validation of Manufacturing Execution Systems (MES) and ensure compliance with internal procedures and regulatory requirements.
Partner with Business Owners, Technical Owners, Quality Assurance (QA), Manufacturing, Engineering, and IT teams to develop validation deliverables and system requirements.
Assist with User Acceptance Testing (UAT) by supporting protocol execution, documenting test results, investigating test failures, and ensuring testing complies with established procedures.
Develop system requirements and specifications for computerized systems used in GxP manufacturing operations.
Perform risk-based validation activities in accordance with GAMP methodology.
Ensure compliance with cGMP, GxP, GAMP, SDLC, and 21 CFR Part 11 regulations governing computerized systems and electronic records.
Support change control, incident management, and system lifecycle activities using IT service management tools.
Collaborate with cross-functional teams to resolve validation issues and maintain audit-ready documentation.
Provide on-site support throughout User Acceptance Testing (UAT) execution.

Requirements / Qualifications:

Bachelor's degree in Life Sciences, Engineering, Information Technology, Computer Science, or a related discipline (or equivalent industry experience).
4+ years of experience in Computer System Validation (CSV) within a GxP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment.
Strong hands-on experience with Manufacturing Execution Systems (MES) validation (e.g., Emerson Syncade).
Strong understanding of Computer System Validation (CSV) principles and validation lifecycle activities.
Experience developing and executing CSV documentation, including:
Validation Plans
User Requirements Specifications (URS)
Functional/Design Specifications
Risk Assessments
IQ/OQ/PQ Protocols
Validation Summary Reports
Traceability Matrices
Standard Operating Procedures (SOPs)
Strong knowledge of GAMP 5, 21 CFR Part 11, cGMP, GxP, SDLC, and Good Documentation Practices (GDP).
Experience with User Acceptance Testing (UAT), protocol drafting, execution, and defect management.
Familiarity with ERP systems (e.g., SAP, Oracle) and Electronic Batch Records (EBR) systems (e.g., InfoBatch).
Experience with Quality Management Systems (e.g., Veeva) and IT Service Management tools (e.g., ServiceNow).
Knowledge of pharmaceutical manufacturing, laboratory systems, and biologics manufacturing processes.
Excellent technical writing, communication, problem-solving, and cross-functional collaboration skills.
Ability to work independently while managing multiple validation activities in a fast-paced, regulated environment.

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: 214c285c644d292e225f82a486a95a71
Posted 8 days ago

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