Sr Engineer

Sr Engineer with experience supporting manufacturing/process engineering activities, system configuration, and support (including DME and PLM), CPV activities, controlled documentation, and manufacturing process monitoring.

The candidate should have good analytical skills to evaluate manufacturing/process data and identify trends, but we are not looking for expertise in statistical modeling, machine learning, or advanced programming. Tools such as Excel, JMP, and Power BI would support the role rather than define it.

Technical Skills:

• Experience supporting manufacturing process and operations in a GxP/GMP environment, with a solid understanding of process performance, equipment, and manufacturing workflows.
• Experience with manufacturing systems and processes such as DME, PLM, Change Control, MMP/MPP management, and Continuous Process Verification (CPV).
• Experience supporting controlled document and process changes, including document updates, coordination of reviews and approvals, implementation activities, and associated GMP documentation.
• Experience supporting Continuous Process Verification (CPV) activities, including process data review, evaluation of process performance and variability, identification of trends, preparation of periodic CPV reports and presentations, and escalation of potential process performance issues.
• Ability to interpret manufacturing and process data to support process monitoring, investigations, troubleshooting, and continuous improvement activities.
• Strong proficiency with Excel and experience with process data trending, analysis, and visualization tools such as JMP and/or Power BI.
• Ability to perform system configuration activities, including understanding business and process requirements, evaluating configuration needs, implementing, or supporting configuration changes, testing changes, documenting results, and troubleshooting system or process issues.
• Experience working with controlled documentation, data integrity requirements, and GMP systems, and change management processes.
• Familiarity with SQL for data querying, troubleshooting, data verification, and investigation of system or process-related issues is preferred.
• Familiarity with digital tools and automation solutions used to improve manufacturing workflows, reporting, process monitoring, or system activities is considered a plus.
• Familiarity with tools such as Smartsheet and/or Microsoft 365 solutions, Power BI, Power Query, Power Automate, SQL, or similar technologies is considered a plus.
• Knowledge of manufacturing processes, including equipment, devices, packaging, and/or process operations, is preferred.
• Experience supporting APR, CPV, process monitoring, manufacturing performance reporting, and/or continuous improvement activities is considered a strong plus.

Requirements

• Doctorate or Masters + 2 years of Engineering experience or Bachelors in Engineering + 4 years of Engineering experience (Chemical, Mechanical or Electrical Engineer)
• Bachelor degree in Engineering, such as Chemical, Mechanical, Electrical, Industrial, Biomedical, or related engineering discipline.
• Experience supporting manufacturing operations in a regulated GxP/GMP environment is highly desirable.
• Process, equipment, device, and/or packaging knowledge is considered a strong plus.
• Bilingual (English & Spanish)