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Associate Engineer

$61.15k - $76.44k

Stryker

Associate Engineer – Manufacturing Execution Systems (MES) Summary The Associate Engineer supports engineering projects by coordinating design, evaluation, testing, and implementation activities. Working under direct supervision, this role assists with technical analysis, documentation, and project support while gaining hands‑on experience within a structured engineering environment. Enhanced Focus This role serves as a Subject Matter Expert for MES and automated production equipment within a 24/7 medical manufacturing environment. The Associate Engineer will drive digital transformation by optimizing Rockwell Automation PharmaSuite objects and integrating complex workflows to ensure high‑fidelity material tracking and data integrity. Essential Responsibilities 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 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. This list is not exhaustive. Additional duties may be assigned by the supervisor as business needs require. Knowledge, Skills, and Abilities 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. Qualifications Required 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 (L6BB). 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. Physical Requirements 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. Work Environment 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. Occasional business travel required (approximately 5%). Occasional on‑call Engineering Support (approximately 5%). Salary Range: $61,150-$76,438 B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, veteran status, marital status, or other legally protected status. #J-18808-Ljbffr

Vacancy posted 3 days ago
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