Top 35 Industrial engineers Jobs in Aguadilla, Pr

Project Validation Specialist II - 60622 (Añasco)
One Group —Añasco, PR
- Extended hours
- Background check
- Spanish
- OSHA
Quick Apply
12d
Product Engineer – Repair Operations
Hewlett Packard Enterprise —Aguadilla, PR
- Full-time
- Spanish
- DevOps
- English
Test Engineer – Repair Operations
Hewlett Packard Enterprise —Aguadilla, PR
- Full-time
- Computer science
- Computer Science
- Office
Quality Assurance Engineer
CIQA Engineering Puerto Rico —Aguadilla, PR
- $35 - $45 an hour
- Full-time
- Engineering
- Mid-level
- 3 years
Quick Apply
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
Staff Engineer, LSS Black Belt
Integra LifeSciences —Añasco, PR
- $73,000 - $102,000 a year
- Email
- Engineering
- Office
- Mentoring
- Disability insurance
- Health insurance
Validation Specialist I - 60624 (Añasco)
One Group —Añasco, PR
- Extended hours
- Background check
- Spanish
- Microsoft Excel
Quick Apply
1d
Validation Specialist III - 60702 (Añasco)
One Group —Añasco, PR
- Extended hours
- Background check
- Spanish
- 6 years
Quick Apply
1d
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
12d
Validation Engineer
Flexible & Integrated Technical Services, LLC —Añasco, PR
- Spanish
- Customer service
- Engineering
Quick Apply
4d
Product Development Engineer, Industrial Flexible Films
Novolex —United States
- $100,000 - $120,000 a year
- Full-time
- Up to 50% travel
- Customer service
- Engineering
- Wellness program
- Paid parental leave
Maintenance Superintendent
Top Wood Jobs —United States
- $90,000 - $150,000 a year
- Online Application
- Word processing
- Mid-level
- Microsoft Office
- Relocation assistance
Design Engineering Manager - Injection Molding
Everforth —United States
- $100,000 - $150,000 a year
- Full-time
- Management
- 5 years
- Fair chance
- Health insurance
5d
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
Mold Design Engineer
Everforth —United States
- $75,000 - $90,000 a year
- Full-time
- Mid-level
- 3 years
- Fair chance
- Health insurance
5d

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industrial engineers jobs near aguadilla, pr

Project Validation Specialist II - 60622 (Añasco)

One Group
Añasco, PR

Quick Apply

Job Details

Full-time | Contract
12 days ago

Qualifications

Spanish
EPA
Teamwork
Content creation for technical audiences
Quality management standards in production
Procedural guides
Bachelor of Science
Engineering
Technical writing experience within manufacturing
Gap analysis
English
Manufacturing standard operating procedures
Bachelor's degree in engineering
Production validation processes
Bachelor's degree
Medical device manufacturing facility experience
Quality control documentation
Pharmaceutical company experience
Compliance documentation
Biomedical regulatory compliance
Cross-functional collaboration
Test validation method
Standard operating procedures (SOPs)
ISO 13485
Cross-functional communication
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

Professional services contract.

Please read all carefully before applying.

Duration: Depends on project's 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 EUMDR is a must.

Responsibilities:

The position is to support the European Union Medical Device Regulation (EU MDR) program. The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of products manufactured, included in the EU MDR program:
Data Gathering – Participate in the discovery and compilation of required documentation to be evaluated.
Gap Assessments – Assess of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures, labeling), process flow charts, incoming inspections, in-process inspections, final inspections, validation plans and process validations, among others.
Remediation Plan – Perform tasks identified as part of the remediation plan including, but not limited to: validation documentation generation and execution (change control, validation plans, validation protocols, validation closure reports, technical reports / memos) and manufacturing documentation update through site change orders system.

The incumbent will be working with cross functional areas on activities described above. Responsible for the delivery of tasks to ensure conformance to the project plan schedule.

Perform assessments and review of all manufacturing and validation documentation associated to product families established by EU MDR program. Provide data to support the gap assessments reports and identify remedial action items based on the outcome of gap assessments. Complete assigned remediation activities to ensure that manufacturing processes and operations are in compliance with requirements of EU MDR. Generate and execute validation protocols, including the coordination of all activities required for protocol completion. Interact and coordinate activities with other departments, external vendors, and customers, as required. Update documentation associated with manufacturing processes which can include drawings, specifications, bill of materials, production router/instructions, procedures, labeling, and process flow charts, among others. Provide training in the updated manufacturing documentation as applicable. Analyze manufacturing process information / data, develop, where necessary, technical justification, rationale and/or other information as required by the company to mitigate risk to acceptable level with adequate documentation. Report project status and progress periodically to site management. Perform other related duties, as required.

Work on official documentation to address technical issues on equipment/processes. Perform Remediation activities as deemed required.

Qualifications:

Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
Must have knowledge of European Union Medical Device Regulation (EU MDR 2017/745), European Union Medical Device Directive 2007/47/EC and ISO13485:2016 Medical Devices – Quality Management Systems.
Must have a thorough understanding of verification and validation processes.
Must have excellent communication skills and a strong track record of working cross-functionally.
Experience with managing documents within electronic PLM system.
Must have demonstrated ability to think strategically.
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.
Teamwork oriented and self-starter.

Other Requirements:

Excellent interpersonal and communication skill at all levels.
Fully bilingual (English and Spanish).
Must speak Spanish fluently (native).
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 and weekends 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.
Please, only apply if you are qualified for this position.

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 aguadilla, pr

Project Validation Specialist II - 60622 (Añasco)

Product Engineer – Repair Operations

Test Engineer – Repair Operations

Quality Assurance Engineer

Warehouse Operations Manager

Process Engineer II - VS Neuro/BioPatch/FP

Staff Engineer, LSS Black Belt

Validation Specialist I - 60624 (Añasco)

Validation Specialist III - 60702 (Añasco)

Project Validation Specialist III for EU MDR Program (2662)

Validation Engineer

Product Development Engineer, Industrial Flexible Films

Maintenance Superintendent

Design Engineering Manager - Injection Molding

Sand Plant Manager

Injection Process Engineer

Mold Design Engineer

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