JT710 - SR. ENGINEER

QUALITY CONSULTING GROUP, a leader in the 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 change Technical (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