Top 178 Controls engineer Jobs in Vietnam 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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Senior Engineer
Amgen —Municipio de Juncos, PR
- $115,494.60 - $156,257.40 a year
- Doctoral degree
- Master's degree
- High school diploma or GED
- Disability insurance
- Health insurance
Automation Engineer
Orise —Guaynabo, PR
- Computer science
- Computer Science
- 5 years
PLC Programmer
Caribe Water Technology —Caguas, PR
- Engineering
- Mid-level
- Associate's degree
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Sr Engineer
CMM Validation & Engineering Solutions, LLC. —Juncos, PR
- $50 - $52 an hour
- Full-time
- Spanish
- Doctoral degree
- Engineering
Quick Apply
Senior Automation Engineer
Orise —Guaynabo, PR
- Computer Science
- English
- Analysis skills
Sr. Engineer (Packaging & Validation) 35333
Inteldot —Municipio de Juncos, PR
- Contract
- Engineering
- System design
- Continuous improvement
Quick Apply
Senior Manager Environmental Engineer
Ryder System —San Juan, PR
- $140,000 - $160,000 a year
- Microsoft Word
- Engineering
- Travel
- Disability insurance
- Health insurance
Quality Assurance & Customer Support Engineer
Hewlett Packard Enterprise —San Juan, PR
- Full-time
- Hybrid work
- Computer Science
- Mid-level
- Office
Principal Manufacturing Systems Engineer
Amgen —Municipio de Juncos, PR
- Doctoral degree
- ERP systems
- Master's degree
- Disability insurance
- Health insurance
Automation Engineer
ATS Automation Tooling Systems Inc. —Guaynabo, PR
- Computer science
- Computer Science
- 5 years
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
Process Engineer I
MiniMed —Municipio de Juncos, PR
- Full-time
- Microsoft PowerPoint
- Spanish
- Word processing
4d
Automation Technitian
JC Automation Corp —Carolina, PR
- $25 - $35 an hour
- Full-time
- Spanish
- Microsoft Excel
- English
Quick Apply
Engineering Technician I
MiniMed —Municipio de Juncos, PR
- Full-time
- High school diploma or GED
- Trade school
- Fair chance
Automation Technical Lead
Real Physics —Carolina, PR
- $88,000 - $98,000 a year
- Contract
- 8 years
- Travel
- Mentoring
Quick Apply
Robotics/Logistics Technical Lead
Real Physics —Carolina, PR
- $85,000 - $93,000 a year
- Contract
- System design
- Continuous improvement
- Travel
Quick Apply
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
Sr Manufacturing Engineer
Inteldot —Dorado Municipio, PR
- Contract
- 5 years
- Mentoring
- In-person
Quick Apply

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controls engineer jobs near vietnam 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.

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Refine Your Search

controls engineer jobs in vietnam pr

Computer System Validation Engineer - Medical Device Equipment & Regulations

Control System Engineer/Technical Architect

Senior Engineer

Automation Engineer

PLC Programmer

Sr Engineer

Senior Automation Engineer

Sr. Engineer (Packaging & Validation) 35333

Senior Manager Environmental Engineer

Quality Assurance & Customer Support Engineer

Principal Manufacturing Systems Engineer

Automation Engineer

Lead Control Systems Engineer - DeltaV

Process Engineer I

Automation Technitian

Engineering Technician I

Automation Technical Lead

Robotics/Logistics Technical Lead

Lead Control Systems Engineer - Rockwell

Sr Manufacturing Engineer

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