Senior Engineer - GMP Packaging & Validation Lead

RiseMe; Juncos (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

Quality Consulting Group, LLC seeks an experienced QA/Engineering professional to lead commissioning and qualification efforts in pharmaceutical manufacturing across Puerto Rico and the USA. You will design strategies, execute IQ/OQ/PQ protocols, and oversee validation documentation for complex systems.

The role requires a Bachelor’s in Engineering (Packaging preferred), GMP/GDP knowledge, and strong project management. Collaboration with QA, Manufacturing, and Supply Chain is essential.

Qualifications

• Bachelor's degree in Engineering, Packaging Engineering, or related technical field.
• Strong knowledge of GMP and GDP in pharmaceutical manufacturing.
• Experience writing test protocols and performing packaging/material testing.
• Familiarity with packaging materials and related components.

Responsibilities

• Characterize and optimize processes in operations, manufacturing, or capital projects.
• Develop and implement C&Q strategy and qualification plans.
• Lead commissioning activities including IQ/OQ/PQ and testing.
• Ensure documentation complies with GMP, FDA, EMA, and internal standards.

Skills

Project management

Technical problem-solving

Interpersonal skills

Written/verbal communication

Education

Bachelor's degree in Engineering, Packaging Engineering, or related technical field

Tools

GMP knowledge

GDP knowledge

Job description

Quality Consulting Group, LLC seeks an experienced QA/Engineering professional to lead commissioning and qualification efforts in pharmaceutical manufacturing across Puerto Rico and the USA. You will design strategies, execute IQ/OQ/PQ protocols, and oversee validation documentation for complex systems.

The role requires a Bachelor’s in Engineering (Packaging preferred), GMP/GDP knowledge, and strong project management. Collaboration with QA, Manufacturing, and Supply Chain is essential.