Sr. Engineer

Summary We are seeking a highly skilled and motivated Senior Engineer to support manufacturing operations within a regulated environment. This role will be responsible for providing technical leadership, supporting process improvements, leading investigations, and collaborating cross-functionally to ensure operational excellence, process robustness, and compliance with regulatory requirements. Responsibilities Own change controls related to manufacturing process changes Support major and trend deviation investigations throughout the full lifecycle Conduct Root Cause Analysis investigations and determine Corrective and Preventive Actions (CAPA) Author technical investigation reports and support regulatory inspections Support Risk Assessment exercises and microbial assessment evaluations Lead commercial campaign readiness activities and collaborate effectively with cross-functional teams Assist in the development of training materials and provide technical/scientific process training Provide manufacturing support and troubleshooting on the production floor Design, coordinate, and support execution of functional tests, water tests, and process challenge runs during major changes or campaign readiness Generate technical protocols and related documentation as needed Assist and provide guidance during Master Batch Record (MBR) creation and revisions Perform assessments supporting process, automation, or equipment modifications and implementation of special projects Initiate, revise, and approve standard manufacturing procedures while ensuring procedures reflect current operations Serve as document owner for manufacturing procedures Assess process performance and analyze operational data to identify and implement process improvement opportunities Complete CAPA applicability assessments for other plants/sites Support assessments for new or revised Bills of Materials (BOMs) Serve as a recognized technical specialist with responsibility for determining methodologies within assigned areas Qualifications Doctorate Degree OR Master’s Degree + 2 years of Engineering experience OR Bachelor’s Degree in Engineering + 4 years of Engineering experience Educational background in Life Sciences and/or Engineering In-depth experience in bioprocessing unit operations Knowledge of Root Cause Analysis methodologies including Fishbone, Six Boxes, 5 Why’s, Kepner-Tregoe Familiarity with Lean Manufacturing practices Ability to communicate and collaborate effectively with technical and management teams across manufacturing, process development, and quality organizations Proficiency in GDP (Good Documentation Practices) within regulated environments Experience using systems such as: Trackwise, Spotfire, CDOCS, Process monitoring platforms Strong technical writing and presentation skills Excellent verbal and written communication skills in both English and Spanish Job Type: Full-time Pay: $45.00 - $50.00 per hour Experience: Lean Manufacturing practices : 5 years (Preferred) GDP (Good Documentation Practices: 5 years (Preferred) Trackwise: 5 years (Preferred) Spotfire: 5 years (Preferred) CDOCS: 5 years (Preferred) Process monitoring platforms : 5 years (Preferred) technical writing : 5 years (Preferred) bioprocessing unit operations : 5 years (Preferred) Root Cause Analysis methodologies : 5 years (Preferred) Fishbone: 5 years (Preferred) Six Boxes: 5 years (Preferred) 5 Why’s: 5 years (Preferred) Kepner-Tregoe : 5 years (Preferred) Work Location: In person