Top 61 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
Quick Apply
Control System Engineer/Technical Architect
Macpower Digital Assets Edge Private Limited —San Juan, PR
- $45 an hour
- System design
- Senior level
- Communication skills
Quick Apply
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
Engineer System Owner - Packaging
Amgen —Municipio de Juncos, PR
- Extended hours
- Spanish
- Engineering
- English
- Disability insurance
- Health insurance
5d
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
Computer Technician - IT
Insight Communications —San Juan, PR
- $18,720 - $24,960 a year
- 8 hour shift
- Computer Science
- Mid-level
- Office
Quick Apply
Senior Mechanical Engineer 1 - Nuclear
Sargent & Lundy —San Juan, PR
- Full-time
- Hybrid work
- Spanish
- Management
- 5 years
- Paid parental leave
- Health savings account
11d
Engineering Technician VI
Advanced IT Concepts LLC —Guaynabo Municipio, PR
- Full-time
- Background check
- Construction site
- Engineering
Lead Primary Engineer
Linxon —Guaynabo, PR
- Full-time
- Conflict management
- Mentoring
- Senior level
- Health insurance
- Retirement plan
Mechanical Engineer P.E
Kundlas Consulting Group LLC —San Juan, PR
- Writing skills
- Master's degree
- Analysis skills
Quick Apply
IT Systems/Net Work Engineer
Kundlas Consulting Group LLC —San Juan, PR
- Azure
- Computer Science
- System design
Quick Apply
Systems Engineer
Fortinet —San Juan, PR
- Full-time
- Mid-level
HVAC Systems Utilities Engineer
Flexible & Integrated Technical Services, LLC —Carolina, PR
- Spanish
- Customer service
- 5 years
Quick Apply
Systems/Software Engineer III Cloud & On-Premise Software Development
Hewlett Packard Enterprise —San Juan, PR
- Full-time
- Computer science
- Computer Science
- Software troubleshooting
4d
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
Senior Wireless Technical Support Engineer
Hewlett Packard Enterprise —San Juan, PR
- Full-time
- 6 years
- Computer Science
- Writing skills
Senior Systems/Software Engineer Cloud & On-Premise Software Development
Hewlett Packard Enterprise —San Juan, PR
- Full-time
- Computer science
- 6 years
- Computer Science
4d
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
Principal Systems/Software Engineer Cloud & On-Premise Software Development
Hewlett Packard Enterprise —San Juan, PR
- Full-time
- Computer science
- Computer Science
- Software troubleshooting
4d

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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

Electrical Design Engineer (Building Systems)

System Application Analyst

Engineer System Owner - Packaging

Mechanical Engineer 3 - Nuclear

Computer Technician - IT

Senior Mechanical Engineer 1 - Nuclear

Engineering Technician VI

Lead Primary Engineer

Mechanical Engineer P.E

IT Systems/Net Work Engineer

Systems Engineer

HVAC Systems Utilities Engineer

Systems/Software Engineer III Cloud & On-Premise Software Development

Lead Control Systems Engineer - DeltaV

Senior Wireless Technical Support Engineer

Senior Systems/Software Engineer Cloud & On-Premise Software Development

Lead Control Systems Engineer - Rockwell

Principal Systems/Software Engineer Cloud & On-Premise Software Development

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