Top 57 Validation engineer Jobs in Aguadilla, Pr

Sealing Validation Specialist II - 60715 (Añasco)
One Group —Añasco, PR
- Extended hours
- Background check
- Spanish
- Microsoft Excel
Quick Apply
7d
Validation Specialist III - 60702 (Añasco)
One Group —Añasco, PR
- Extended hours
- Background check
- Spanish
- 6 years
Quick Apply
Engineer II, Data Analytics & Machine Learning (Hybrid - Aguadilla, PR)
Collins Aerospace —Aguadilla, PR
- Full-time
- Hybrid work
- English
- Mid-level
- Office
- Disability insurance
- Health insurance
20h
Systems Engineer II - Integrated Systems
Honeywell Aerospace —Aguadilla, PR
- Full-time
- Mid-level
- Travel
Systems Engineer II - Display Services
Honeywell Aerospace —Aguadilla, PR
- Full-time
- Mid-level
- Travel
Validation Engineer
Flexible & Integrated Technical Services, LLC —Añasco, PR
- Spanish
- Customer service
- Engineering
Quick Apply
7d
Advanced Systems Engineer - Integrated Systems
Honeywell Aerospace —Aguadilla, PR
- Full-time
- Travel
- Mentoring
- Senior level
- Relocation assistance
Senior Software Engineer, Verification & Validation (Hybrid)
Collins Aerospace —Aguadilla, PR
- Full-time
- Hybrid work
- English
- Research
- Windows
- Disability insurance
- Health insurance
Hardware Technologies Engineering Manager (Hybrid - Aguadilla, PR)
Collins Aerospace —Aguadilla, PR
- Full-time
- Hybrid work
- English
- 3 years
- Analysis skills
- Disability insurance
- Health insurance
Validation Engineer - Packaging
Flexible & Integrated Technical Services, LLC —Añasco, PR
- Weekends as needed
- Spanish
- Customer service
- Engineering
Quick Apply
7d
Product Security Compliance - Senior Security SW and System Engineer
Hewlett Packard Enterprise —Aguadilla, PR
- Full-time
- 6 years
- Computer Science
- Writing skills
AI Software Developer
Hewlett Packard Enterprise —Aguadilla, PR
- Full-time
- Hybrid work
- Computer science
- Azure
- Computer Science
Systems Engineer II, Communications (Onsite - Security Clearance)
Collins Aerospace —Aguadilla, PR
- Full-time
- English
- Mid-level
- In-person
- Disability insurance
- Health insurance
Sr Advanced Systems Engineer - Flight Management Systems
Honeywell Aerospace —Aguadilla, PR
- Full-time
- Travel
- Senior level
Senior Systems Engineer, Infrastructure (Hybrid - Aguadilla, PR)
Collins Aerospace —Aguadilla, PR
- Full-time
- Hybrid work
- Azure
- Laboratory experience
- English
- Disability insurance
- Health insurance
Software Engineer, Test Equipment (Hybrid - Aguadilla, PR)
Collins Aerospace —Aguadilla, PR
- Full-time
- Hybrid work
- System design
- English
- Mid-level
- Disability insurance
- Health insurance
Senior Systems Engineer, Communications (Onsite - Security Clearance)
Collins Aerospace —Aguadilla, PR
- Full-time
- English
- 3 years
- In-person
- Disability insurance
- Health insurance
Sr Advanced Systems Engineer
Honeywell Aerospace —Aguadilla, PR
- Full-time
- Databases
- Senior level
9d
Senior Software Engineer (Onsite - Secret Clearance)
Collins Aerospace —Aguadilla, PR
- Full-time
- Computer science
- Management
- Computer Science
- Disability insurance
- Health insurance
Electrical Engineer
CONTROL AUTOMATION TECHNOLOGIES INC —Puerto Rico
- $50,000 - $75,000 a year
- Full-time
- Mid-level
- Analysis skills
- Electrical Engineering
- Health insurance
- Dental insurance
Quick Apply

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Sealing Validation Specialist II - 60715 (Añasco)

One Group
Añasco, PR

Quick Apply

Job Details

Full-time | Contract
7 days ago

Qualifications

Spanish
Teamwork
Content creation for technical audiences
Medical device testing
Technical documentation
Bachelor of Science
Engineering
Technical writing experience within manufacturing
Gap analysis
English
Cleanroom protocols
Manufacturing standard operating procedures
Manufacturing facility experience
Records management
Production validation processes
Bachelor's degree
Medical device manufacturing facility experience
Cleanroom gowning procedures
Pharmaceutical company experience
System testing
Compliance documentation
Cleanroom experience
Investigative reports
Standard operating procedures (SOPs)
Packaging equipment
Mechanical product validation projects
Cross-functional communication
FDA regulations
Standard operating procedures drafting
Pharmaceutical manufacturing facility experience

Full Job Description

Title: Sealing Validation Specialist II - 60715 (Añasco)

Job Type: Professional services contract.

Duration: Depends on project schedule (long term)

Where: Añasco, On-Site

Hour Rate: Depends on the expertise. Negotiable

MINIMUM QUALIFICATIONS

Education and/or experience:

BS in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering or related science.
Must have experience in the medical device and/or pharmaceutical manufacturing environment; on a project validation engineer position.
Must have experience on packaging and sterility barrier testing, and sealing machines validation activities for sterile and non-sterile medical devices.

Responsibilities:

We are seeking a motivated Validation Specialist to support the Project Engineering Department in packaging testing, and validation activities for sterile and non-sterile medical devices. This position will work closely with senior packaging and project engineers to support packaging system implementation, technical documentation, testing coordination, and continuous improvement initiatives within a regulated medical device manufacturing environment.

The ideal candidate is a hands-on team player with strong organizational and communication skills, a technical curiosity, and a willingness to develop packaging engineering expertise through practical project experience.

Exposure to medical device packaging validation, regulatory requirements, and cross-functional project execution.

The selected individual must also demonstrate flexibility and availability to support different shifts and weekend activities as business needs require.

Skills:

Packaging engineering principles and validation processes.
Ability to follow established procedures, protocols, and engineering guidance.
Understanding of engineering concepts and manufacturing processes.

Qualifications:

Must be able to develop technical documentation such as: Change Controls, Validation Plans, Gap Assessments, Validation Protocols (IQ/OQ/PQ), Technical / investigation reports, SOP, and others.
Knowledge of FDA QSR, ISO 13485, ISO 9001, or GMP environments preferred.
Exposure to laboratory testing, validation activities, or statistical analysis is preferred.
Execution of packaging studies, validation protocols, and engineering evaluations under the guidance of senior engineers.
Collect, organize, analyze, and document testing data to support validation efforts and engineering decisions.
Support Engineering activities through setup, sample preparation, data collection, and documentation activities.
Assist with technical documentation including protocols, reports, test summaries, specifications, and change records.
Coordinate activities with cross-functional teams including Quality, Operations, Regulatory and Product Development.
Support troubleshooting activities related to packaging performance, manufacturing, or testing issues.
Assist with risk assessments, continuous improvement initiatives, and process optimization projects.
Ensure compliance with internal procedures, FDA QSR, ISO 13485, ISO 9001, MDR, CDMR, and applicable regulatory requirements.
Maintain accurate project records and support timely completion of assigned deliverables.
Participate in packaging line trials, validation builds, and manufacturing support activities as needed.
Provide on-site support across different shifts and weekends as required by project and operational needs.
Demonstrate initiative, accountability, and willingness to learn new technical skills and regulatory requirements.

Other Requirements:

Ability to work in ISO 7-class cleanroom environments using required gowning for extended periods of time.
Proficiency in Microsoft Office applications (Excel, Word, PowerPoint preferred).
Experience with managing documents within electronic PLM system.
Good organizational and time management skills.
Basic analytical and problem-solving abilities.
Excellent interpersonal and communication skills at all levels.
Fully bilingual (English and Spanish). Must speak Spanish fluently (native).
Strong track record of working cross-functionally.
Must have demonstrated ability to think strategically.
Teamwork oriented and self-starter.
Need to have full attention to details.
Skills in working under time pressure.
Availability to work extended hours in a day. Flexibility to support multiple shifts and weekend activities if required.
Available to start as soon as possible.
Must live in Puerto Rico. No relocation nor travel expenses available.
Resumes must be in English.
We seek experienced professionals; no training will be given on the position requirements.
Please note: This position does not offer visa sponsorship. Applicants must be fluent in both Spanish and English. Kindly refrain from applying if you do not meet these requirements. No C2C available.
Are you a match? Please apply to Indeed position or send your updated resume to [email protected]. Please include the job title in the subject line.

Job Types: Full-time, Contract

Application Question(s):

Do you have an engineering or related science bachelor degree?

Education:

Bachelor's (Required)

Experience:

Project Validation Engineer: 3 years (Required)

Language:

Spanish (Required)
English (Required)

Ability to Commute:

Añasco, PR 00610 (Required)

Work Location: In person

Quick Apply

Refine Your Search

validation engineer jobs in aguadilla, pr

Sealing Validation Specialist II - 60715 (Añasco)

Validation Specialist III - 60702 (Añasco)

Engineer II, Data Analytics & Machine Learning (Hybrid - Aguadilla, PR)

Systems Engineer II - Integrated Systems

Systems Engineer II - Display Services

Validation Engineer

Advanced Systems Engineer - Integrated Systems

Senior Software Engineer, Verification & Validation (Hybrid)

Hardware Technologies Engineering Manager (Hybrid - Aguadilla, PR)

Validation Engineer - Packaging

Product Security Compliance - Senior Security SW and System Engineer

AI Software Developer

Systems Engineer II, Communications (Onsite - Security Clearance)

Sr Advanced Systems Engineer - Flight Management Systems

Senior Systems Engineer, Infrastructure (Hybrid - Aguadilla, PR)

Software Engineer, Test Equipment (Hybrid - Aguadilla, PR)

Senior Systems Engineer, Communications (Onsite - Security Clearance)

Sr Advanced Systems Engineer

Senior Software Engineer (Onsite - Secret Clearance)

Electrical Engineer

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