Sr Engineer - 35953

Position Summary
We are seeking a highly motivated Sr. Engineer to support manufacturing operations in a regulated GMP/GxP environment. This position will play a key role in manufacturing process support, system configuration and maintenance, Continuous Process Verification (CPV), controlled documentation management, process monitoring, and continuous improvement initiatives. The successful candidate will collaborate cross-functionally to ensure manufacturing processes remain compliant, efficient, and aligned with quality and operational objectives.
The ideal candidate will possess strong engineering and analytical skills, hands-on experience supporting manufacturing operations, and the ability to evaluate process and system performance to identify opportunities for improvement and operational excellence.

Key Responsibilities

• Support day-to-day manufacturing operations to ensure process reliability, compliance, and operational efficiency.
• Monitor manufacturing processes, equipment, and systems to identify performance trends and opportunities for improvement.
• Support Continuous Process Verification (CPV) activities, including data analysis, trend identification, report generation, presentations, and escalation of process performance concerns.
• Participate in manufacturing investigations, troubleshooting efforts, root cause analysis, and implementation of corrective and preventive actions.
• Support manufacturing systems configuration and maintenance activities, including requirement assessment, testing, implementation, documentation, and troubleshooting.
• Manage and support process and system changes through established Change Control processes.
• Coordinate and support controlled document updates, reviews, approvals, and implementation activities while maintaining GMP compliance.
• Support Manufacturing Process Plans (MPP/MMP), Device Master Engineering (DME), Product Lifecycle Management (PLM), and related manufacturing systems.
• Analyze manufacturing and process data to support process monitoring, process performance evaluation, and operational decision-making.
• Prepare and maintain technical reports, process documentation, CPV reports, performance metrics, and presentations.
• Collaborate with Operations, Quality, Validation, Regulatory, Supply Chain, and other cross-functional teams to support manufacturing objectives.
• Support Annual Product Reviews (APR), process monitoring programs, manufacturing performance reporting, and continuous improvement initiatives.
• Ensure compliance with applicable regulatory requirements, GMP standards, company procedures, and data integrity expectations.

Education / Background
• Bachelor's degree in Engineering preferred, such as Chemical, Mechanical, Electrical, Industrial, Biomedical, or related engineering discipline.
• Experience supporting manufacturing operations in a regulated GxP/GMP environment is highly desirable.
• Knowledge of manufacturing processes, equipment, devices, packaging, and/or process operations is considered a strong plus.

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.

General Skills
• Strong engineering, analytical and technical problem-solving skills, with the ability to evaluate manufacturing, process and system issues and identify practical solutions.
• Excellent written and verbal communication skills, with the ability to interact effectively across different communication and working styles.
• Fully bilingual in English and Spanish.