Top 41 Supplier quality engineer Jobs in Puerto Rico

CSV/CQV Engineer – Kneat
JC Automation Corp —Humacao, PR
- Full-time
- Hybrid work
- Computer Science
- Engineering
- Mid-level
Quick Apply
3d
Supplier Quality Engineer
Hewlett Packard Enterprise —San Juan, PR
- Full-time
- Engineering
- Mid-level
- Office
Sr Supplier Quality Engineer
Weil Group, Inc —Juncos, PR
- Temporary
- Bilingual
- Bachelor's degree
- Travel
Quick Apply
Quality Engineer I -
Medtronic —Municipio de Juncos, PR
- Full-time
- Engineering
- Office
- US work authorization
5d
JT270 - SUPPLIER QUALITY ENGINEER I
Quality Consulting Group, LLC —Villalba, PR
- Temporary
- Background check
- Computer literacy
- Engineering
Quick Apply
Quality Engineer
Trane Technologies —Arecibo, PR
- $72,000 a year
- Full-time
- Spanish
- Management
- Customer service
- Paid holidays
- Health insurance
Quality Engineer
C-Axis PR, Inc —Caguas, PR
- $62,000 - $68,000 a year
- Full-time
- Engineering
- Mentoring
- Training & development
Supplier Qual Engineer I
Weil Group, Inc —Villalba Municipio, PR
- Computer literacy
- Engineering
- Continuous improvement
Quick Apply
Quality Engineer
Industrial C&S of P.R. LLC —Arecibo, PR
- Full-time
- Spanish
- Engineering
- English
Quick Apply
13d
Validation Engineer
Validation & Engineering Group —Juncos, PR
- Extended hours
- Engineering
- 8 years
- Programmable logic controllers
Quick Apply
Validation Specialist / Engineer
Validation & Engineering Group —Guaynabo, PR
- Spanish
- Engineering
- Laboratory experience
Quick Apply
Supplier Qual Engineer II
Weil Group, Inc —Villalba Municipio, PR
- Hybrid work
- Computer literacy
- Mid-level
- Continuous improvement
Quick Apply
JT270 - SUPPLIER QUALITY ENGINEER I
Quality Consulting Group —Villalba, PR
- Computer literacy
- Engineering
- English
Supplier Qual Engineer II
ECHO Consulting Group —Villalba Municipio, PR
- Contract
- Hybrid work
- Engineering
- Mid-level
- Continuous improvement
Quick Apply
AQE Engineer
BD —Humacao Municipio, PR
- Spanish
- Engineering
- English
10d
Quality Engineer/ Scientist - CQE CERTIFICATION REQUIRED
Validation & Engineering Group —Carolina, PR
- Spanish
- Word processing
- English
Quick Apply
Sr Quality Engineer
ECHO Consulting Group —Municipio de Juncos, PR
- Contract
- Engineering
- Mentoring
- Senior level
Quick Apply
Senior Quality Engineer
Eaton —Arecibo, PR
- Extended hours
- Spanish
- English
- Windows
Validation Engineer Lead
Validation & Engineering Group —Municipio de Juncos, PR
- Full-time
- Engineering
- Mid-level
- 3 years
Quick Apply
Supplier Quality Engineer II
Flexible & Integrated Technical Services, LLC —Villalba, PR
- Spanish
- Customer service
- Computer literacy
Quick Apply

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CSV/CQV Engineer – Kneat

JC Automation Corp -
Humacao, PR

Quick Apply

Job Details

Full-time
3 days ago

Qualifications

Data integrity assurance
GAMP
Content creation for technical audiences
Requirements specification
Technical documentation
ISO standards
Technical writing experience within manufacturing
FDA 21 CFR Part 11
Quality reports
Data integrity and documentation
Schedule management
Production validation processes
Quality control documentation
Requirements analysis
Compliance documentation
Regulatory/legal compliance standards in production
Collaboration with manufacturing teams
Biomedical regulatory compliance
Commissioning phase involvement
Achieving project delivery timelines
Field commissioning
Cross-functional communication
Test Planning (Quality assurance practices)

Full Job Description

About Company:

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

ABOUT THE ROLE

The CSV/CQV Engineer will support commissioning, qualification, and computer system validation activities for new and modified equipment, utilities, facilities, automated systems, and computerized systems within a regulated pharmaceutical manufacturing environment.

**This is a Chicago-based hybrid position with a primarily remote work arrangement and occasional on-site presence as required by project needs.

This position will work closely with Engineering, Automation, Manufacturing, Quality, IT, system owners, vendors, and other project stakeholders to develop and execute validation strategies and deliverables in accordance with project requirements, company procedures, cGMP requirements, and applicable regulatory standards.

The role requires hands-on experience using Kneat as a paperless validation and qualification platform.

RESPONSIBILITIES

Develop, review, execute, and approve commissioning, qualification, and computer system validation documentation.
Prepare and execute validation plans, User Requirements Specifications, functional and design specifications, risk assessments, traceability matrices, test scripts, protocols, and final reports.
Develop and execute IQ, OQ, and PQ protocols for equipment, utilities, facilities, automated systems, and computerized systems.
Use Kneat to create, route, execute, review, approve, and maintain electronic validation and qualification documentation.
Ensure validation deliverables comply with applicable cGMP requirements, internal procedures, validation standards, and regulatory expectations.
Apply risk-based validation principles in accordance with GAMP 5 and applicable data integrity requirements.
Support Factory Acceptance Testing, Site Acceptance Testing, commissioning, system verification, and equipment release activities.
Evaluate computerized and automated systems to ensure they remain in a validated state throughout their lifecycle.
Support validation activities involving automation systems, PLCs, SCADA, process-control systems, laboratory systems, manufacturing systems, and related interfaces.
Review system changes, deviations, validation discrepancies, and test exceptions, and support the development and implementation of appropriate corrective actions.
Support investigations, CAPAs, change controls, periodic reviews, and requalification or revalidation activities.
Maintain complete, accurate, traceable, and inspection-ready validation documentation.
Collaborate with cross-functional teams and contract validation resources to ensure timely completion of project deliverables.
Provide validation support during internal audits, client audits, and regulatory inspections.
Manage multiple validation activities and priorities while meeting established project schedules.

REQUIREMENTS & QUALIFICATIONS

Required

- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a closely related technical discipline.
- Minimum of three years of experience in commissioning, qualification, computer system validation, quality, engineering, automation, or pharmaceutical manufacturing.
- Demonstrated experience developing and executing CSV and CQV documentation, including IQ, OQ, and PQ protocols.
- Hands-on experience with the Kneat paperless validation platform is required.
- Working knowledge of cGMP, FDA requirements, 21 CFR Part 11, data integrity principles, and GAMP 5.
- Experience with validation lifecycle documentation, risk assessments, requirements traceability, test execution, deviations, and final validation reports.
- Experience with computerized systems, automated manufacturing systems, PLC/SCADA environments, laboratory systems, or process-control systems.
- Ability to interpret technical documentation and translate system requirements into appropriate validation and testing strategies.
- Strong technical writing, analytical, organizational, and problem-solving skills.
- Strong interpersonal and communication skills with the ability to work effectively across Engineering, Quality, Automation, IT, Manufacturing, and external vendors.
- Ability to manage multiple assignments and work independently within established project timelines

Preferred

Experience working in pharmaceutical, biotechnology, medical-device, or another highly regulated manufacturing environment.
Experience supporting system implementation, migration, upgrades, and decommissioning activities.
Knowledge of ALCOA+ data integrity principles.
Experience supporting regulatory inspections and audit-readiness activities.
Experience with change control, CAPA, deviation management, periodic review, and maintaining systems in a validated state.

SKILLS

Technical Skills

Manufacturing process definition, documentation, and standardization
Process KPI and performance monitoring, including OEE, SPC, and manufacturing data systems
Root cause analysis and troubleshooting
Quality systems, compliance, and risk management (GMP, FDA, ISO requirements)
Process change management, including CAPA, change control, and deviation management
Continuous improvement methodologies, including Lean Six Sigma
ERP, MES, and SCADA manufacturing data systems

Soft Skills

Strong problem-solving and analytical thinking
Cross-functional collaboration with Manufacturing, Engineering, Quality, and Maintenance
Clear communication for training and process-change rollout
Leadership in driving continuous improvement initiatives

Chicago-based hybrid position:
3 weeks of remote work and 1 week on-site in Chicago

Quick Apply

Refine Your Search

supplier quality engineer jobs in puerto rico

CSV/CQV Engineer – Kneat

Supplier Quality Engineer

Sr Supplier Quality Engineer

Quality Engineer I -

JT270 - SUPPLIER QUALITY ENGINEER I

Quality Engineer

Quality Engineer

Supplier Qual Engineer I

Quality Engineer

Validation Engineer

Validation Specialist / Engineer

Supplier Qual Engineer II

JT270 - SUPPLIER QUALITY ENGINEER I

Supplier Qual Engineer II

AQE Engineer

Quality Engineer/ Scientist - CQE CERTIFICATION REQUIRED

Sr Quality Engineer

Senior Quality Engineer

Validation Engineer Lead

Supplier Quality Engineer II

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