Associate Engineer
$61.15k - $76.44kB. Braun Melsungen
Associate Engineer
Company: B. Braun US Pharmaceutical Manufacturing LLC
Job Posting Location: Daytona Beach, Florida, United States
Functional Area: Production
Working Model: Onsite
Days of Work: Wednesday, Tuesday, Thursday, Friday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 11579
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
- Coordinate and assist with the design, evaluation, planning, integration, testing, and completion of engineering projects.
- Provide technical direction and guidance to professional and subprofessional personnel, as appropriate.
- Supervise the preparation and maintenance of records related to job expenditures, budgets, work orders, change requests, progress payments, and final contract estimates.
- Assist in preparing technical specifications and related contract documentation for use in project bidding processes.
- Identify, analyze, and support the resolution of program and project support deficiencies.
- Gather, review, and correlate engineering data to support decision-making and reporting. Perform engineering-related tests and accurately document results.
- MES Subject Matter Expertise: Serve as a primary contributor for the deployment, optimization, and troubleshooting of MES objects, including equipment, workflows, and recipes in a GMP pharmaceutical environment.
- System Integration & Reliability: Investigate and resolve HMI/OPC tag disconnect issues and implement advanced logic for exception handling to ensure continuous production uptime and prevent data loss.
- Lifecycle Management: Execute end-to-end migration of validated MES recipes through DEV → QA → PROD lifecycles in strict compliance with change control procedures.
- Continuous Improvement: Analyze Electronic Batch Records (EBRs) and OEE (Overall Equipment Effectiveness) metrics to implement fixes that reduce changeover time and manufacturing scrap.
- Equipment Optimization: Support the performance and reliability of automated systems, including thermoforming machines and robotics, through custom tooling design and process validation.
- Regulatory Compliance: Author SOPs, traceability matrices, and test scripts to ensure adherence to FDA 21 CFR Part 11 and global data integrity standards.
- Basic knowledge of relevant business practices, procedures, and engineering principles.
- Ability to apply standard theories, concepts, and procedures to support engineering tasks.
- Works under direct supervision with detailed verbal and/or written instructions. Uses established procedures to complete assigned tasks effectively.
- Demonstrates sound judgment in resolving routine, day-to-day problems. Communicates effectively with supervisors, team members, and peers; occasional interaction with external vendors or contractors.
- Technical Proficiency: Advanced knowledge of Rockwell Automation PharmaSuite, Recipe/Workflow Designer, and S88-compliant batch manufacturing.
- Digital Tools: Proficiency in programming languages such as Python or SQL for data analysis, and CAD tools (AutoCAD/SolidWorks) for site layout and part engineering.
- Operational Excellence: Understanding of Lean Six Sigma methodologies, root cause analysis (RCA), and 'servant leadership' principles to support cross-functional team alignment.
- Compliance Expertise: Deep understanding of GMP, dual-operator verification, and electronic signature implementation within automated workflows.
- Bachelor's degree in Engineering, Computer Science, or an equivalent combination of education and relevant technical experience.
- 2+ years of related engineering or technical experience, preferably in a pharmaceutical or medical device manufacturing setting.
- Preferred Certifications: Rockwell Automation PharmaSuite Features & Functionality, Data Science/Analytics, or Lean Six Sigma Black Belt (L6σBB).
- Ability to sign and comply with secrecy, invention, and non-compete agreements.
- Flexibility to work non-standard schedules as required to support 24/7 manufacturing operations.
- Ability to perform light work, including lifting and/or moving up to 20 pounds occasionally.
- Regularly required to sit and communicate verbally.
- Frequently required to use hands and arms for handling, reaching, and operating equipment.
- Occasionally required to stand and walk.
- Moderate noise levels.
- Work performed in office, production/manufacturing, and laboratory environments.
- Occasional proximity to moving mechanical parts and limited exposure to chemicals, depending on work area.
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