Senior Process Engineer – GMP, Validation & Process Improvement

qualityconsultinggroup; Juncos (PR); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to join our team in Puerto Rico & USA, focusing on process optimization in pharmaceutical and biotech environments. Responsibilities include applying engineering principles to design and implement major system modifications, developing results analyses, and guiding capital projects.

Candidates should have a Bachelor’s in Engineering and at least 5 years of experience, plus familiarity with GMP/validation and data analytics.

Qualifications

• Bachelor Degree in Engineering.
• 5 years of Engineering experience.
• Experience with data analysis, dashboard development, statistical evaluation, GMP documentation, validation principles, and process improvement.
• Knowledge of AI-enabled or automation tools such as Python, Codex, Power Automate, SQL, or VBA.

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.

Skills

Data analysis

Dashboard development

Statistical evaluation

GMP documentation

Validation principles

Process improvement

Self-motivation

Education

Bachelor Degree in Engineering

Tools

Python

Codex

Power Automate

SQL

VBA

Job description

Quality Consulting Group, LLC is seeking a talented engineer to join our team in Puerto Rico & USA, focusing on process optimization in pharmaceutical and biotech environments. Responsibilities include applying engineering principles to design and implement major system modifications, developing results analyses, and guiding capital projects.

Candidates should have a Bachelor’s in Engineering and at least 5 years of experience, plus familiarity with GMP/validation and data analytics.