Sr Engineer

QRC Group • Juncos, PR

3d

About The Position

The Sr Engineer supports manufacturing and process engineering activities, manufacturing system configuration and support (including DME and PLM), Continuous Process Verification (CPV), controlled documentation, and manufacturing process monitoring. The role uses analytical skills to evaluate manufacturing and process data, identify trends, and support process performance review, investigations, troubleshooting, and continuous improvement. Excel, JMP, and Power BI are tools that support the work; advanced statistical modeling, machine learning, and programming expertise are not required.

The position also supports configuration changes by understanding business and process requirements, evaluating configuration needs, implementing or supporting changes, testing and documenting results, and troubleshooting system or process issues. It involves controlled-document and process changes, including document updates, review and approval coordination, implementation activities, and related GMP documentation.

Requirements

• Doctorate or master's degree plus 2 years of engineering experience, or a bachelor's degree in engineering plus 4 years of engineering experience.
• Bachelor's degree in engineering, such as Chemical, Mechanical, Electrical, Industrial, Biomedical, or a related engineering discipline.
• Experience supporting manufacturing processes and operations in a GxP/GMP environment.
• Understanding of process performance, equipment, and manufacturing workflows.
• Experience with manufacturing systems and processes such as DME, PLM, Change Control, MMP/MPP management, and CPV.
• Experience supporting controlled documentation, data integrity requirements, GMP systems, and change management processes.
• Ability to analyze manufacturing and process data and identify trends.
• Strong proficiency with Excel and experience with process data trending, analysis, and visualization tools such as JMP and/or Power BI.
• Ability to support system configuration activities, test changes, document results, and troubleshoot system or process issues.
• Bilingual in English and Spanish.

Nice To Haves

• Familiarity with SQL for data querying, troubleshooting, data verification, and investigations of system- or process-related issues.
• Familiarity with digital tools and automation solutions used to improve manufacturing workflows, reporting, process monitoring, or system activities.
• Familiarity with Smartsheet and/or Microsoft 365 solutions, Power BI, Power Query, Power Automate, SQL, or similar technologies.
• Knowledge of manufacturing processes, including equipment, devices, packaging, and/or process operations.
• Experience supporting APR, CPV, process monitoring, manufacturing performance reporting, and/or continuous improvement activities.

Responsibilities

• Support manufacturing process and operations in a GxP/GMP environment.
• Support manufacturing systems and processes, including DME, PLM, Change Control, MMP/MPP management, and Continuous Process Verification (CPV).
• Support controlled document and process changes, including document updates, review and approval coordination, implementation activities, and associated GMP documentation.
• Support CPV activities by reviewing process data, evaluating process performance and variability, identifying trends, preparing periodic reports and presentations, and escalating potential performance issues.
• Interpret manufacturing and process data for process monitoring, investigations, troubleshooting, and continuous improvement.
• Perform or support system configuration activities, including requirements review, configuration changes, testing, documentation, and troubleshooting.
• Support APR, process monitoring, manufacturing performance reporting, and continuous improvement activities, as applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior