Process Validation Engineer - 134

Flexible & Integrated Technical Services, LLC • Villalba, PR

3d

About The Position

For Packaging and Sterilization services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor’s Degree in Engineering and two (2) years of experience within the Medical Devices Industry.
Bilingual: Spanish and English
Soft Skills: Writing and communication skills
Shift: 1st and according to business needs.
Experience in:
Ethylene oxide, steam, liquid chemical, and radiation sterilization methods
Process Validation, Equipment IQ, and Computer software validation knowledge
No sterile package design or pharma design
The Personality Part:
Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
Design arrangement of machines within plant facilities to ensure the most efficient and productive layout.
Design sequence of operations and specify procedures for the fabrication of tools and equipment, and other functions that affect product performance.
Adapt machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan.
Inspect performance of machinery, equipment, and tools to verify their efficiency, and investigate and initiate corrective action for problems and deficiencies to ensure product quality.
Develop manufacturing processes that apply to statistical process control and may develop techniques.
Guide engineers regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
Ensure processes and procedures comply with regulations.
WHO WE ARE:
We are a Service Provider company, different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?

Requirements

• Bachelor’s Degree in Engineering and two (2) years of experience within the Medical Devices Industry.
• Bilingual: Spanish and English
• Soft Skills: Writing and communication skills
• Ethylene oxide, steam, liquid chemical, and radiation sterilization methods
• Process Validation, Equipment IQ, and Computer software validation knowledge
• No sterile package design or pharma design

Responsibilities

• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Design arrangement of machines within plant facilities to ensure the most efficient and productive layout.
• Design sequence of operations and specify procedures for the fabrication of tools and equipment, and other functions that affect product performance.
• Adapt machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan.
• Inspect performance of machinery, equipment, and tools to verify their efficiency, and investigate and initiate corrective action for problems and deficiencies to ensure product quality.
• Develop manufacturing processes that apply to statistical process control and may develop techniques.
• Guide engineers regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensure processes and procedures comply with regulations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level