Jt437 - Manufacturing Engineer II
About The Position
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA. Responsibilities: In charge of Process Validation, Equipment IQ and Computer software validation. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.
Requirements
- Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical preferred)
- Minimum of 2 years of relevant experience
- Process Validation and Computer software validation knowledge
- Equipment Validations
- Manage Supplier Change Requests
- Experience with ethylene oxide, steam, liquid chemical, and radiation sterilization methods
- Experience with no sterile package design or pharma package design
- Collaboration and Teamwork with adaptability project tasks requirements
- Communication skills (English / Spanish)
- Problem-Solving Skill and Continuous Improvement Mindset
- Attention to details
Responsibilities
- Process Validation
- Equipment IQ
- Computer software validation
- Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling
- Designs arrangement of machines within plant facilities to ensure most efficient and productive layout
- Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance
- Adapts machine or equipment design to factory and production conditions
- May incorporate inspection and test requirements into the production plan
- Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality
- Develops manufacturing processes that are applicable to statistical process control and may develop those techniques
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
