JT509 - MANUFACTURING ENGINEER II

Quality Consulting Group, LLC; Villalba (PR); On-site; USD 70,000 - 105,000; Full time

Job summary

Quality Consulting Group, LLC in Puerto Rico/USA seeks a talented engineer to design manufacturing processes, layouts and validation procedures for production lines. You will contribute to process design, equipment layout, operation sequences, and statistical techniques to ensure product quality.

Fluency in English and Spanish is required; 1st shift. A Bachelor’s in Engineering and 3+ years of experience are needed.

Qualifications

• Bachelor’s degree in Engineering required.
• 3+ years of relevant experience.
• Process Validation, Equipment IQ and Computer software validation knowledge.
• Technical writing knowledge and communication skills.
• Investigation and root cause analysis skills.
• Must have knowledge in Process Validation, Equipment IQ and Computer software validation.
• Knowledgeable on statistical techniques.
• Excellent writing and communications in English and Spanish.

Responsibilities

• 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 efficient and productive layout.
• Designs sequence of operations and specifies procedures for 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 applicable to statistical process control.

Skills

Technical writing

Communication skills

Root cause analysis

Statistical techniques

Bilingual English/Spanish

Process Validation

IQ/OQ validation

Software validation

English writing

Education

Bachelor’s degree in Engineering

Job description

QUALITY CONSULTING GROUP, a leader inthe 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

• 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.

Qualifications

• Bachelor’s degree in Engineering
• 3+ years of relevant experience
• Process Validation, Equipment IQ and Computer software validation knowledge
• Technical writing knowledge and Communication skills
• Investigation and root cause analysis skills
• Must have knowledge in Process Validation, Equipment IQ and Computer software validation
• Provides technical and sustaining engineering support in a manufacturing area; therefore, investigation and root cause analysis skills are required to solve problems or improve effectiveness of job area (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)
• Knowledgeable on statistical techniques
• In addition, the resource needs to be schedule oriented in order to meet projects objectives and assignments without impacting deadlines and it is really important for the resource to have good writing skills and communication skills in English and Spanish to have successful and productive meetings within a cross functional team
• Shift: 1st shift