JT710 - SR. ENGINEER

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to join our team in the Puerto Rico and USA operations. The role involves leading process optimization studies, troubleshooting manufacturing and capital project issues, and applying advanced engineering principles to major system modifications.

Ideal candidates will have a Bachelor’s degree in engineering and at least 5 years of engineering experience, with familiarity in data analysis, dashboard development, and GMP documentation.

Qualifications

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

Responsibilities

• Independently characterizes optimization strategies and troubleshoots issues in operations, manufacturing, pilot plant or capital projects.
• Applies advanced engineering principles to design and implement major system modifications, experiments, and capital projects.
• Develops and presents results interpretation for operational issues or engineering projects of significant scope and complexity.
• Completes complex assignments requiring new engineering techniques and procedures.
• Develops engineering policies and procedures affecting multiple units.
• Supervises, coordinates, and reviews work of engineers, associates, and/or technicians on ongoing and project bases.
• Applies mature engineering knowledge in planning and conducting projects.

Skills

data analysis

dashboard development

statistical evaluation

GMP documentation

Education

Bachelor Degree in Engineering

Tools

Python

Codex

Power Automate

SQL

VBA

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 Degree in Engineering
• 5 years of Engineering experience
• Preferred qualifications include 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. Experience supporting Drug Product manufacturing, characterization studies, engineering runs, PPQ, validation deliverables, or manufacturing readiness activities will be a plus.
• Self-driven, comfortable working with ambiguous business needs, and able to translate operational challenges into practical digital tools, dashboards, or process improvements.
• Validation Protocol Writing
• Dealing with and managing changeTechnical (Equipment Specific)
• Working knowledge of pharmaceutical/biotech processes
• Familiarity with validation processes
• Familiarity with documentation in a highly regulated environment
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Able to develop solutions to routine technical problems of limited scope
• 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.