Job Summary: Responsible for real-time monitoring, control, and documentation of sterilization processes, ensuring adherence to validated parameters, safety standards, and quality requirements. Key Highlights: 1. Manages and monitors sterilization processes through SCADA. 2. Ensures compliance with GMP, ISO 13485, and FDA 21 CFR 820 regulations. 3. Participates in continuous improvement and promotes process safety. **Job Description** **General Description:** Responsible for real-time monitoring, control, and documentation of sterilization processes via the SCADA system. This position ensures that all sterilization cycles are executed fully in compliance with validated parameters, safety standards, and quality system requirements. **Responsibilities:** **Operational Management: Technical and Engineering Ownership of the Process** * Operate and monitor sterilization chambers, preconditioning rooms, aeration rooms, gas supply systems, and abatement systems via SCADA. * Initiate, pause, resume, or abort cycles per validated procedures and work instructions. * Verify critical parameters in real time: temperature, pressure/vacuum, EO concentration, humidity, and exposure time. * Ensure only approved recipes and validated cycle parameters are used. * Perform trend analysis and statistical process control on critical parameters. * Monitor and respond to system alarms and deviations. * Conduct Level 1 troubleshooting using alarm logic and SOPs. * Serve as the communication hub among floor operators, maintenance, quality, EHS, and supervisors. * Document abnormal events and deviations in logbooks or electronic systems. * Provide clear shift handovers and operational status reports. * Support training of new operators on SCADA and process logic. * Participate in emergency response drills and simulations. * Ensure strict adherence to EO safety procedures. * Support investigations, CAPAs, and audit requirements. * Ensure data integrity and system traceability. * Act as backup to the Production Supervisor and assume their responsibilities as required during absences. **Quality and Regulatory Compliance:** * Ensure compliance with Good Manufacturing Practices (GMP) and applicable medical device regulations. * Ensure compliance with: * **1\.** ISO 13485 * **2\.** FDA 21 CFR 820 * **3\.** ISO 11135 (EO Sterilization) * **4\.** Data Integrity and ALCOA+ * Verify that any system modification is supported by an approved Change Control and current documented review. * Ensure correct implementation of procedures, work instructions, and process controls. * Collaborate on corrective and preventive actions (CAPA) arising from internal/external audits or deviations. * Collaborate closely with Quality and Regulatory Affairs during internal and external audits. * + Participate in deviation investigations. **Continuous Improvement and Operational Excellence:** * Execute transformation toward a culture of operational excellence. * Implement and ensure adherence to Medline’s operational systems (5S, standardized work, daily management, etc.) in the control room. * Actively participate in Kaizen events and continuous improvement projects. * Contribute operational data for Lean or Six Sigma analyses led by Sterilized Product Assurance (QA) or Leadership. * Identify improvement opportunities in: SCADA visualization (clearer screens, prioritized alarms), automated reporting, and predictive alarms via trending. * Provide input to develop executive performance dashboards. **Safety and Risk Management:** * Ensure strict adherence to EO handling safety protocols. * Monitor EO detection systems in real time and immediately report any readings exceeding permissible limits established by EHS and applicable regulations. * Verify operational status of critical ventilation and abatement systems prior to cycle start-up. * Participate as an operational SME in process risk analyses (HAZOP, FMEA) when required. * Lead operational risk assessments related to: gas leaks, abatement failures, pressure issues, ventilation system failures, among others. * Collaborate with EHS on: * **1\.** Emergency response plans * **2\.** Drills * **3\.** Incident investigations * **4\.** Promoting a behavior-based safety culture. * **5\.** Ensuring no operational improvement compromises personnel safety or environmental compliance. * **6\.** Developing proactive process safety indicators (e.g., near-misses of critical alarms, response times to deviations). * **7\.** This position is responsible for promoting the principle: “Process Safety Before Productivity.” **Education:** * Industrial Engineering, Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Business Administration, or related field. **Experience:** * 0–1 years of experience in this role * Conversational English **Skills:** * Operational leadership * Strategic thinking * Data-driven decision making * Effective communication * Results orientation & Change management * Statistical analysis tools (Minitab or equivalent) * Basic Lean Six Sigma knowledge * Basic Lean Manufacturing & Continuous Improvement knowledge * Basic P&ID interpretation, basic PLC system knowledge. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.
Juan García
Indeed · HR
Juan García
Indeed · HR
