Top 59 System engineer Jobs in San Juan Pr

Computer System Validation Engineer - Medical Device Equipment & Regulations
Macpower Digital Assets Edge Private Limited —San Juan, PR
- $45 an hour
- Organizational skills
- Software development
- Senior level
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Control System Engineer/Technical Architect
Macpower Digital Assets Edge Private Limited —San Juan, PR
- $45 an hour
- System design
- Senior level
- Communication skills
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Systems Engineer
Fortinet —San Juan, PR
- Full-time
- Mid-level
IT Systems/Net Work Engineer
Kundlas Consulting Group LLC —San Juan, PR
- Azure
- Computer Science
- System design
Quick Apply
Junior Microsoft 365 / Endpoint Administrator (Tier 1–2)
Paradigm Alternative Investments LLC —Santurce, PR
- Full-time
- Windows
- SharePoint
- Fair chance
- Health insurance
- Dental insurance
Quick Apply
13d
Senior Wireless Technical Support Engineer
Hewlett Packard Enterprise —San Juan, PR
- Full-time
- 6 years
- Computer Science
- Writing skills
Help Desk Support Level 2 - Managed Service Provider
K2 Staffing, LLC —Guaynabo, PR
- $17 - $19 an hour
- Full-time
- Remote
- Spanish
- English
- Mid-level
Quick Apply
Help Desk Support Level 2 - Managed Service Provider
K2 Staffing —Guaynabo, PR
- Full-time
- Remote
- Spanish
- English
- Mid-level
Quick Apply
Lead Control Systems Engineer - DeltaV
RoviSys —San Juan, PR
- $60,000 - $95,000 a year
- Full-time
- Bachelor of Science
- Mid-level
- Windows
- Health insurance
- Dental insurance
Aveva PI Lead Engineer- Remote
Cognizant —San Juan, PR
- $120,000 - $132,000 a year
- Full-time
- Hybrid work
- Microsoft Word
- Windows
- SQL
- Paid parental leave
- Employee stock purchase plan
Lead Control Systems Engineer - Rockwell
RoviSys —San Juan, PR
- $75,000 - $100,000 a year
- Full-time
- Management
- 5 years
- Bachelor of Science
- Health insurance
- Dental insurance
Computer Technician - IT
Insight Communications —San Juan, PR
- $18,720 - $24,960 a year
- 8 hour shift
- Computer Science
- Mid-level
- Office
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Mechanical Engineer 3 - Nuclear
Sargent & Lundy —San Juan, PR
- Full-time
- Hybrid work
- Spanish
- Microsoft Excel
- Bachelor of Science
- Paid parental leave
- Health savings account
9d
Engineering Technician VI
Advanced IT Concepts LLC —Guaynabo Municipio, PR
- Full-time
- Background check
- Construction site
- Engineering
Electrical Design Engineer (Building Systems)
INTEGRA Design Group —San Juan, PR
- Full-time
- Spanish
- English
- Mid-level
System Application Analyst
The Cervantes Group —Guaynabo, PR
- Full-time
- Spanish
- English
- Mid-level
9d
Mechanical Engineer P.E
Kundlas Consulting Group LLC —San Juan, PR
- Writing skills
- Master's degree
- Analysis skills
Quick Apply
Principal Manufacturing Systems Engineer
Amgen —Municipio de Juncos, PR
- Doctoral degree
- ERP systems
- Master's degree
- Disability insurance
- Health insurance
Associate Lab Computing Analyst
Tailored Management —San Juan, PR
- $13.47 - $14.71 an hour
- 8 hour shift
- Writing skills
- Mid-level
- Windows
- Health insurance
- Dental insurance
Quick Apply
Aveva PI Lead Engineer - Remote
Cognizant —San Juan, PR
- 12 hour shift
- Hybrid work
- 8 years
- Continuous improvement
- Mentoring

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system engineer jobs near san juan pr

Computer System Validation Engineer - Medical Device Equipment & Regulations

Macpower Digital Assets Edge Private Limited
San Juan, PR

Quick Apply

Job Details

$45 an hour

Qualifications

Data integrity assurance
Compliance risk assessment
Bug Tracking (Quality assurance practices)
Data validation techniques
Test Case Documentation (Quality assurance practices)
Systems architecture experience within technology
Strategy Development (Quality assurance practices)
Bug Reporting (Quality assurance practices)
FDA 21 CFR Part 11
ICH Q9
Data summary reports
Quality reports
Data integrity and documentation
Quality risk management
Quality control documentation
Issue tracking
Software documentation
Software development
Biomedical regulatory compliance
Technical project management
Defect tracking tools
Regulatory compliance analysis
Document change management
Cross-functional collaboration
Test validation method
Cross-functional communication
Test Planning (Quality assurance practices)
Stakeholder management

Full Job Description

Job Summary:

Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance.
Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles.
Compliance Analysis, Validation Planning, Risk Assessments
Test planning and strategy
creation and execution of test protocols, scripts and reports.
Validation Summary Reports, traceability analysis.
Defect Logging and Tracking till closure.

Responsibilities:

Develop, approve, and execute validation deliverables for computerized systems, including validation plans, risk assessments, and traceability matrices.
Author and update documentation to support ongoing CSV compliance.
Prepare or review all levels of validation documents including:
Validation (Strategy) Plans, User Requirement Specifications
Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs
Qualification Documents and Test Specifications (IQ, OQ, PQ)
Traceability Matrices, Risk Analysis
Validation Reports, Change Controls/ Events / Deviations etc
Assess the impact of changes proposed to computerized systems and the level of change required.
Provide validation strategy to the introduction of computerized systems.
Collaborate with the key stakeholders (Information Systems, Software assurance, business users and suppliers etc) and management on all related matters on a regular basis.

Must Have:

GxP and Regulatory Knowledge: You should have a strong understanding of Good Manufacturing Practice (GxP) regulations and their application in computerized systems, as well as knowledge of relevant regulations like FDA 21 CFR Part 11 and International Standards (e.g., EU Annex 11, ICH Q7, and GAMP 5).
Computer System Validation (CSV): You must have hands-on experience with the full lifecycle validation of computerized systems, ensuring compliance from system design to retirement. You should also be capable of developing and executing validation strategies and plans based on industry standards like GAMP 5.
Risk Assessment: You need to be able to perform risk assessments to identify potential risks and assess the impact of system changes, ensuring the right level of validation is applied.
Testing & Documentation: You should be proficient in test planning and strategy, including the creation and execution of test protocols and scripts such as IQ, OQ, and PQ. Additionally, you must have experience in defect tracking and preparing comprehensive validation reports with clear traceability.
Project Management: Strong organizational skills are essential to manage and prioritize tasks in a regulated environment, while also collaborating effectively with cross-functional teams and managing stakeholder expectations.
Change Control Management: You must be familiar with change control procedures to assess the impact of system changes and prepare or review relevant documentation, including deviations and changes to system processes.
Technical Knowledge: A good understanding of the software development life cycle (SDLC) and system architecture is necessary, along with data validation expertise to ensure the integrity and reliability of system data.
Software Tools: Familiarity with CSV tools and validation management software (e.g., Veeva Vault QMS, MasterControl, Trackwise) is important for efficient document management and validation tracking.

Quick Apply

Refine Your Search

system engineer jobs in san juan pr

Computer System Validation Engineer - Medical Device Equipment & Regulations

Control System Engineer/Technical Architect

Systems Engineer

IT Systems/Net Work Engineer

Junior Microsoft 365 / Endpoint Administrator (Tier 1–2)

Senior Wireless Technical Support Engineer

Help Desk Support Level 2 - Managed Service Provider

Help Desk Support Level 2 - Managed Service Provider

Lead Control Systems Engineer - DeltaV

Aveva PI Lead Engineer- Remote

Lead Control Systems Engineer - Rockwell

Computer Technician - IT

Mechanical Engineer 3 - Nuclear

Engineering Technician VI

Electrical Design Engineer (Building Systems)

System Application Analyst

Mechanical Engineer P.E

Principal Manufacturing Systems Engineer

Associate Lab Computing Analyst

Aveva PI Lead Engineer - Remote

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