Top 202 Computer 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
Cybersecurity Vulnerability Analyst
Popular Bank —San Juan, PR
- Hybrid work
- Computer science
- Azure
- Computer Science
5d
Contract Software Engineer - AI Trainer
DataAnnotation —San Juan, PR
- $50 - $100 an hour
- Part-time
- Remote
- Writing skills
- English
- Mid-level
- Flexible schedule
Quick Apply
Cybersecurity Lead Engineer
Careers Inc —San Juan, PR
- $1 - $2 a year
- Full-time
- 6 years
- Computer Science
- Software troubleshooting
Quick Apply
Developer - AI Trainer
DataAnnotation —Puerto Rico
- $50 - $100 an hour
- Part-time
- Remote
- Writing skills
- English
- Mid-level
- Flexible schedule
Quick Apply
Sr Data Engineer/ Scientist
Kelly Services —Juncos, PR
- $48 an hour
- Full-time
- Spanish
- Computer science
- Computer Science
- Paid holidays
- Disability insurance
Quick Apply
Sr. Engineer
Weil Group, Inc —Juncos, PR
- Temporary
- Bilingual
- Background check
- Computer literacy
Quick Apply
4d
Sr. Engineer
Weil Group, Inc —Juncos, PR
- Temporary
- Background check
- Doctoral degree
- Computer literacy
Quick Apply
Engineering Technician I
MiniMed —Municipio de Juncos, PR
- Full-time
- High school diploma or GED
- Trade school
- Fair chance
4d
Facilities Engineer SME
Validation & Engineering Group, Inc —Carolina, PR
- Full-time
- Bachelor of Science
- Analysis skills
- Organizational skills
Quick Apply
3d
Data Engineer
Bella Group —San Juan, PR
- Azure
- Computer Science
- Mid-level
7d
Junior Integration Developer
Consertus —Guaynabo, PR
- Full-time
- Computer science
- Computer Science
- SQL
- Health insurance
- Dental insurance
Cloud Data Engineer
Hewlett Packard Enterprise —San Juan, PR
- Full-time
- Computer science
- Computer Science
- Mid-level
Senior Software Engineer
CEGSoft —San Juan, PR
- $70,000 - $76,000 a year
- Full-time
- Hybrid work
- Spanish
- Azure
- Computer Science
Quick Apply
Computer Technician - IT
Insight Communications —San Juan, PR
- $18,720 - $24,960 a year
- 8 hour shift
- Computer Science
- Mid-level
- Office
Quick Apply
AI Cyber Defense Engineer - Emerging Risks
Popular Bank —San Juan, PR
- Hybrid work
- Azure
- Computer Science
- 5 years
9d
Engineer
Cencora —Juncos, PR
- Extended hours
- Spanish
- Computer literacy
- Engineering
- Paid parental leave
- Health insurance
Lead Software Engineer
CEGSoft —San Juan, PR
- $75,000 - $85,000 a year
- Full-time
- Hybrid work
- Spanish
- Azure
- Computer Science
Quick Apply
Senior Applied AI Engineer
BOLD —Guaynabo, PR
- Hybrid work
- Azure
- Computer Science
- System design
- Disability insurance
- Health insurance
Quick Apply
11d
Quality Assurance & Customer Support Engineer
Hewlett Packard Enterprise —San Juan, PR
- Full-time
- Hybrid work
- Computer Science
- Mid-level
- Office

I want to receive the latest job alert for computer engineer in san juan, pr

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

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

computer engineer jobs in san juan, pr

Computer System Validation Engineer - Medical Device Equipment & Regulations

Cybersecurity Vulnerability Analyst

Contract Software Engineer - AI Trainer

Cybersecurity Lead Engineer

Developer - AI Trainer

Sr Data Engineer/ Scientist

Sr. Engineer

Sr. Engineer

Engineering Technician I

Facilities Engineer SME

Data Engineer

Junior Integration Developer

Cloud Data Engineer

Senior Software Engineer

Computer Technician - IT

AI Cyber Defense Engineer - Emerging Risks

Engineer

Lead Software Engineer

Senior Applied AI Engineer

Quality Assurance & Customer Support Engineer

I want to receive the latest job alert for computer engineer in san juan, pr

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected