Manufacturing Process Engineer II: Validation & Process Excellence

Quality Consulting Group, LLC; Villalba (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to design manufacturing processes, layouts, and procedures across pharmaceutical, biotech, medical devices, and manufacturing sectors in Puerto Rico and the USA. The role emphasizes process validation, equipment IQ, and software validation, with strong technical writing and bilingual communication in English and Spanish.

The ideal candidate holds a Bachelor's degree in Engineering, has 3+ years of experience, and can work in a

Qualifications

• Bachelor's degree in Engineering required.
• 3+ years of relevant experience.
• Process Validation, Equipment IQ and Computer software validation knowledge.
• Technical writing and communication skills.
• Investigation and root cause analysis skills.
• Knowledgeable in statistical techniques.
• Bilingual in English and Spanish for cross-functional meetings.
• Shift: 1st shift.

Responsibilities

• Design manufacturing processes, procedures and layouts for assemblies, equipment installation, processing, machining and material handling.
• Designs arrangement of machines within plant facilities to ensure efficient layout.
• Defines sequence of operations and procedures for fabrication of tools and equipment.
• Adapts machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspects machinery performance to verify efficiency and initiates corrective actions to ensure quality.
• Develops processes applicable to statistical process control (SPC).

Skills

Process validation

Root cause analysis

Technical writing

Bilingual EN/ES

Project scheduling

Education

Bachelor's degree in Engineering

Tools

Statistical software

Plant systems knowledge

Job description

Quality Consulting Group, LLC is seeking a talented engineer to design manufacturing processes, layouts, and procedures across pharmaceutical, biotech, medical devices, and manufacturing sectors in Puerto Rico and the USA. The role emphasizes process validation, equipment IQ, and software validation, with strong technical writing and bilingual communication in English and Spanish.

The ideal candidate holds a Bachelor's degree in Engineering, has 3+ years of experience, and can work in a