Associate Engineer

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.

This role serves as a Subject Matter Expert (SME) for Manufacturing Execution Systems (MES) and automated production equipment within a 24/7 medical manufacturing environment. The Associate Engineer will drive digital transformation by optimizing Rockwell Automation Pharma Suite objects and integrating complex workflows to ensure high-fidelity material tracking and data integrity.

• 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 life cycles 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.

This list is not exhaustive. Additional duties may be assigned by the supervisor as business needs require.

• 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 Pharma Suite, 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/Solid Works) 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…