JT953 - SR. 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,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:

• Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
• Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects.
• Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
• Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• Develop engineering policies and procedures that affect multiple organizational units.
• Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
• Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
• Application of mature engineering knowledge in planning and conducting projects.

Qualifications:

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, Industrial, Biomedical, or related field).

• Experience in manufacturing operations within a regulated GxP/GMP environment.

• Knowledge of manufacturing processes, equipment, packaging, and process operations.

• Experience with manufacturing systems and processes, including DME, PLM, Change Control, MMP/MPP, and Continuous Process Verification (CPV).

• Experience managing controlled documentation, GMP records, process changes, and system configuration.

• Ability to analyze manufacturing and process data, identify trends, monitor process performance, and support investigations and continuous improvement.

• Experience preparing CPV reports, presentations, and manufacturing performance reports.

• Strong proficiency in Microsoft Excel; experience with JMP, Power BI, Power Query, and SQL is a plus.

• Ability to support system configuration, testing, troubleshooting, and process improvements.

• Familiarity with Microsoft 365, Smartsheet, and automation tools is desirable.

• General Skills

• Strong analytical, engineering, and problem-solving skills.

• Excellent written and verbal communication skills.

• Fully bilingual in English and Spanish.
• Administrative Shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.