Top 25 Industrial Engineers Jobs in Mayagüez, PR

Validation Specialist I - 60624 (Añasco)
One Group —Añasco, PR
- Extended hours
- Background check
- Spanish
- Microsoft Excel
Quick Apply
3d
Validation Specialist III - 60702 (Añasco)
One Group —Añasco, PR
- Extended hours
- Background check
- Spanish
- 6 years
Quick Apply
3d
Product Engineer – Repair Operations
Hewlett Packard Enterprise —Aguadilla, PR
- Full-time
- Spanish
- DevOps
- English
Warehouse Operations Manager
BD —Añasco, PR
- Spanish
- Microsoft Excel
- Customer service
Process Engineer II - VS Neuro/BioPatch/FP
Integra LifeSciences —Añasco, PR
- $42,000 - $59,000 a year
- Email
- Spanish
- Management
- Engineering
- Disability insurance
- Health insurance
Test Engineer – Repair Operations
Hewlett Packard Enterprise —Aguadilla, PR
- Full-time
- Computer science
- Computer Science
- Office
Staff Engineer, LSS Black Belt
Integra LifeSciences —Añasco, PR
- $73,000 - $102,000 a year
- Email
- Engineering
- Office
- Mentoring
- Disability insurance
- Health insurance
Project Validation Specialist II - 60622 (Añasco)
One Group —Añasco, PR
- Extended hours
- Background check
- Spanish
- OSHA
Quick Apply
14d
Validation Engineer
Flexible & Integrated Technical Services, LLC —Añasco, PR
- Spanish
- Customer service
- Engineering
Quick Apply
6d
Project Validation Specialist III for EU MDR Program (2662)
MEDCHEM ENGINEERING SERVICES LLC —Añasco, PR
- $33 - $36 an hour
- Full-time
- Background check
- Spanish
- 7 years
Quick Apply
14d
Sand Plant Manager
ResponsAble Staffing —United States
- Mentoring
- Senior level
- Leadership
Quick Apply
Injection Process Engineer
Logoplaste —United States
- From $100,000 a year
- Full-time
- 5 years
- Research
- Travel
- Health savings account
- Relocation assistance
Quick Apply

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Industrial Engineers jobs near Mayagüez, PR

Validation Specialist I - 60624 (Añasco)

One Group
Añasco, PR

Quick Apply

Job Details

Full-time | Contract
3 days ago

Qualifications

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

Full Job Description

Title: Validation Specialist I - 60624 (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 Mechanical Engineering, Industrial Engineering, Chemical Engineering or related science.
Experience in the medical device and/or pharmaceutical manufacturing environment; on a project validation engineer position.
Experience on packaging testing, and validation activities for sterile and non-sterile medical devices.
Internship, co-op, or academic project experience within medical devices, manufacturing, quality, or packaging is preferred.

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

Industrial Engineers jobs in Mayagüez, PR

Validation Specialist I - 60624 (Añasco)

Validation Specialist III - 60702 (Añasco)

Product Engineer – Repair Operations

Warehouse Operations Manager

Process Engineer II - VS Neuro/BioPatch/FP

Test Engineer – Repair Operations

Staff Engineer, LSS Black Belt

Project Validation Specialist II - 60622 (Añasco)

Validation Engineer

Project Validation Specialist III for EU MDR Program (2662)

Sand Plant Manager

Injection Process Engineer

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