Top 18 Senior validation engineer Jobs in Manatí Pr

Senior Manufacturing Engineer
Weil Group, Inc —Dorado, PR
- Temporary
- Background check
- Bachelor's degree
- Mentoring
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8d
Sr Engineer
Validation & Engineering Group, Inc —Manatí, PR
- Extended hours
- Engineering
- Mid-level
- 2 years
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Engineering - Senior Process Engineer
Viant Medical —Vega Baja, PR
- Full-time
- 5 years
- Bachelor of Science
- Bachelor's degree
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2d
Sr Manufacturing Engineer
Inteldot —Dorado Municipio, PR
- Contract
- 5 years
- Mentoring
- In-person
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12d
Sr. Process Engineer, Energy Remanufacturing
Tesla —Vega Alta, PR
- Full-time
- Engineering
- Analysis skills
- Mentoring
Sr Manufacturing Engineer (Second Shift)
Eaton —Arecibo, PR
- Extended hours
- Spanish
- English
- Windows
9d
Manufacturing Engineer & Sr. Manufacturing Engineer
Exceed, LLC —Dorado, PR
- Full-time
- Mid-level
- Analysis skills
- Mentoring
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11d
Senior Automation Project Engineer
HR Works —Manatí Municipio, PR
- $40 - $55 an hour
- Weekends as needed
- Spanish
- Computer Science
- Engineering
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11h
Senior Healthcare Integration Consultant - EDI 834 & Eligibility
Proactive Logic Consulting Inc —United States
- $75 - $110 an hour
- Contract
- Remote
- System design
- HIPAA
- Java
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Senior Electrical Commissioning Engineer (Data Centers)
CAI —United States
- $91,300 - $107,300 a year
- Full-time
- Hybrid work
- Microsoft Word
- Construction site
- Customer service
- Disability insurance
- Health insurance
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senior validation engineer jobs near manatí pr

Senior Manufacturing Engineer

Weil Group, Inc
Dorado, PR

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Job Details

Temporary | Full-time
8 days ago

Qualifications

Statistics
Industrial automation
Teamwork
New product introduction engineering projects
Project engineering
Content creation for technical audiences
Defect resolution root cause analysis
Engineering development testing
Quality control statistical data analysis
Preventive action implementation
Regulatory compliance
Statistical Process Control
Tooling design
Technical writing experience within manufacturing
Production deviation management
Value stream mapping
Corrective and preventive actions (CAPA)
Project management experience in manufacturing
Minitab
Bachelor's degree in engineering
Production validation processes
Bachelor's degree
Technology transfer (scale-up process)
Leading team collaboration initiatives
Biomedical regulatory compliance
Root cause analysis
Test validation method
Mechanical knowledge
ISO 13485
Cross-functional communication

Full Job Description

Role Summary
The Senior Manufacturing Engineer leads enterprise manufacturing operations support, validation strategy, implementation of manufacturing processes, documentation generation, process optimization, and cross-functional technical execution. The role is expected to operate with a high degree of independence, provide technical leadership to project teams, and mentor junior engineers or technical team members as needed.

Key Responsibilities

Lead IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.
Design and develop in-process and receiving inspection systems, control plans, sampling plans, and inspection methods for components and manufacturing processes.
Generate, review, and approve equipment documentation, PM/calibration procedures, manufacturing instructions, and process control documentation.
Manage enterprise manufacturing projects from concept through implementation; lead cross-functional technical collaboration with Manufacturing, Quality, R&D, Regulatory, Supply Chain, and external suppliers as applicable.
Apply DOE, PFMEA, risk analysis, SPC, MSA, and root-cause methodologies to characterize, optimize, and improve manufacturing processes.
Lead Lean Manufacturing and continuous improvement initiatives to improve yield, cycle time, cost, throughput, process capability, and equipment performance.
Provide technical direction for manufacturing technologies such as laser welding, heat bonding, injection molding, vision systems, fixtures, tooling, test methods, automation, and equipment qualification.
Support change control, CAPA, nonconformance investigations, and product/process scale-up activities while maintaining compliance with site quality procedures.

Experience Requirements

Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Biomedical Engineering, or related technical field.
5-7+ years in manufacturing engineering, process engineering, validation engineering, or quality engineering within an FDA-regulated environment.
Strong working knowledge of 21 CFR Part 820, GMP, ISO 13485, and documentation practices required in regulated manufacturing environments.
Electrical and mechanical engineering background applied to automated or semi-automated manufacturing systems.
Experience with automation/controls, tooling, fixtures, test method development, equipment qualification, and manufacturing process validation.
Proficiency in DOE, FMEA/PFMEA, CAPA, root-cause investigation, statistical analysis, and process capability tools; experience with Minitab, JMP, or equivalent preferred.
Experience with Lean Manufacturing, Six Sigma, Kaizen, value stream mapping, or other continuous improvement methodologies preferred.
Experience supporting product introductions, process scale-up, design transfer, and improvements to existing manufacturing processes.
Strong project management, communication, technical writing, analytical, and cross-functional leadership skills.

Quality Expectations
Demonstrates commitment to patient safety and product quality by complying with all applicable quality procedures.
Ensures proper documentation discipline and supports Quality System compliance while providing technical guidance to others as needed.

*Weil Group is proud to be an Equal Employment Opportunity Employer.*
#IND2

Education:

Bachelor's (Required)

Experience:

Mechanical, Electrical, Industrial,: 6 years (Preferred)
Manufacturing, Biomedical or related technical field: 6 years (Preferred)
manufacturing & process engineering: 6 years (Preferred)
validation or quality engineering: 6 years (Preferred)
FDA-regulated environment: 6 years (Preferred)
21 CFR Part 820, GMP, ISO 13485: 6 years (Preferred)
documentation practices: 6 years (Preferred)
automated or semi-automated manufacturing systems: 6 years (Preferred)
automation/controls, tooling, fixtures: 6 years (Preferred)
test method development: 6 years (Preferred)
equipment qualification, process validation: 6 years (Preferred)
DOE, FMEA/PFMEA, CAPA, root-cause investigation: 6 years (Preferred)
statistical analysis, and process capability tools: 6 years (Preferred)
Minitab, JMP: 6 years (Preferred)

Work Location: In person

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Refine Your Search

senior validation engineer jobs in manatí pr

Senior Manufacturing Engineer

Sr Engineer

Engineering - Senior Process Engineer

Sr Manufacturing Engineer

Sr. Process Engineer, Energy Remanufacturing

Sr Manufacturing Engineer (Second Shift)

Manufacturing Engineer & Sr. Manufacturing Engineer

Senior Automation Project Engineer

Senior Healthcare Integration Consultant - EDI 834 & Eligibility

Senior Electrical Commissioning Engineer (Data Centers)

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