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