Junior Automation Engineer to support the development, improvement and maintenance of automated production systems. This role contributes to enhancing product quality, operational efficiency and safety while assisting engineering projects, equipment upgrades, and facility modifications.
Duties:
Support automation systems and troubleshooting. Automation support includes - assembly machines/fixtures, label applicator, robots, end of arms, separators and test equipment.Support planning, scheduling, and execution of engineering projects.Help analyze production data to ensure automation meets output and OEE targets.Support continuous improvement efforts to enhance quality, safety and efficiency of automated processes.Support compliance with FDA Quality System Regulation, cGMP, ISO Standards and internal quality systems.
Requirements:
BS Engineering (Electrical, Mechanical, Automation or related) and 2 or more years of experience.Basic understanding of automation, robotics, sensors, PLC's, or machine safety.Knowledge in project management and continuous improvementBilingual (Spanish/English; written and spoken)Technical WritingRead Less
Process Validation Specialist with experience in ethylene oxide (ETO) sterilization processes comply with applicable regulatory, quality, and industry standards, guaranteeing process effectiveness, reproducibility, and safety for medical or industrial products.
Responsibilities:
Develop, execute, and document IQ/OQ/PQ validation protocols for ETO sterilization processes.Conduct load configuration studies, gas penetration tests, thermal distribution assessments, and residuals evaluations.Analyze microbiological, physicochemical, and process performance data.Ensure compliance with applicable standards such as ISO 11135, ISO 10993-7, ISO 13485, and FDA/EMA regulations.Manage process changes through impact assessments and revalidations.Prepare technical reports, scientific justifications, and supporting documentation for internal and external audits.Collaborate with Quality, Engineering, Manufacturing, and Supplier teams to resolve deviations or nonconformities.Participate in continuous improvement initiatives, process optimization, and reduction of ETO residuals.Maintain and update standard operating procedures (SOPs) related to sterilization.Requirements
Bachelor Degree Engineering (Industrial, Chemical, Biomedical), Microbiology, Sciences, or related fields)4 years of experience in process validation (ETO)Strong understanding of ETO sterilization processes and critical parameters (humidity, temperature, concentration, exposure time).Solid knowledge of microbiology applied to sterilization.Proficiency with statistical analysis tools (Minitab, JMP, etc.).Experience in process validation within regulated environments.Familiarity with quality management systems (QMS).Ability to interpret international standards and regulatory requirements.Validation Engineer with experience in automated equipment and vision system validation (protocol generation, execution, and reporting).
Experience in generating manufacturing procedures and preventive maintenance. Strong knowledge generating validation documents: Installation and Operational Qualification (IOQ), Operational Qualification (OQ), Process Characterization, Performance Qualification (PQ), SOP, and PM procedures.
Experience:
Validating two semi-automated packaging lines with the following equipment:
Line 1:
Material Cleaning SystemsCollaborative RobotsEFD for Lubrication ProcessCognex Vision System for Inspection.Line 2:
Automated Box ErectorZebra Printers and Label ApplicatorsCognex Vision System for Label InspectionSemi-Automatic Case Former and SealerCheckweigherAutomated Palletizer (collaborative Robots)Automated Stretch WrapperRequirements:Bachelor in Engineering or SciencesAt least 4 years or experience with regulated industriesBilingual (Spanish/English)(written and spoken)Technical writing
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