Senior Manufacturing & Process Optimization Engineer

Quality Consulting Group; Juncos (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

QUALITY CONSULTING GROUP, LLC is a leader in the pharmaceutical, biotech, medical devices, and manufacturing industries, seeking a talented engineer to join our team in Puerto Rico & USA. You will work with a team on world-class manufacturing projects, focusing on process optimization and CPV reporting.

The role requires a Bachelor’s degree in Engineering and experience in regulated environments, with strong Excel and data analysis skills, plus English/Spanish bilingual capabilities.

Qualifications

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, Industrial, Biomedical, or related field).
• Experience in manufacturing operations within a regulated GMP/GxP environment.
• Experience with manufacturing systems and processes (DME, PLM, Change Control, CPV).
• Experience managing controlled documentation and GMP records.
• Strong data analysis and trend identification skills.
• Proficiency in Excel; knowledge of JMP, Power BI, SQL is a plus.
• Fully bilingual in English and Spanish.
• Administrative shift responsibilities.

Responsibilities

• Independently characterizes and directs optimization strategies in operations, manufacturing, pilot plant or capital projects.
• Applies engineering principles to major system modifications and experiments.
• Develops analysis and presents results for operational issues or projects of significant scope and complexity.
• Completes complex assignments requiring new engineering techniques and procedures.
• Develops engineering policies and procedures affecting multiple units.
• Supervises engineers, associates and technicians on projects and on an ongoing basis.
• Applies advanced techniques within engineering expertise and related fields.
• Supports CPV and manufacturing performance reporting.

Skills

GxP / GMP knowledge

Process optimization

Data analysis

Excel

Power BI

SQL

English fluency

Spanish fluency

Education

Bachelor's degree in Engineering

Tools

DME

PLM

CPV tooling

Power BI

Power Query

SQL

Job description

QUALITY CONSULTING GROUP, LLC is a leader in the pharmaceutical, biotech, medical devices, and manufacturing industries, seeking a talented engineer to join our team in Puerto Rico & USA. You will work with a team on world-class manufacturing projects, focusing on process optimization and CPV reporting.

The role requires a Bachelor’s degree in Engineering and experience in regulated environments, with strong Excel and data analysis skills, plus English/Spanish bilingual capabilities.