Senior Associate Manufacturing Systems Engineer
Grupo STT
- San Juan San Juan, PR
- Temporary
- Full-time
- Ensure the maintenance team training program, standard operating procedures and equipment/system operational standards are consistent throughout the team.
- Participate in the coordination of technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues and process maintenance issues.
- Assist the maintenance team during FDA and other regulatory agency inspections. Provide technical support to the maintenance team in response to the FDA and other regulatory agencies.
- Assist the maintenance team when responding to high purity water systems and environmental monitoring alert/action notifications. Assist with the investigation on all alert/action notifications.
- Assist with the development and maintenance of an audit program for the maintenance team and facilitate routine audits of activities, documentation, operations and related areas to ensure a continued state of compliance.
- Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
- Assist with the testing of proposed sanitization and maintenance procedure changes and modifications for process, utility and clean room systems.
**Other functions that may be assignedRequisitos
- Trabajo presencial en Juncos; Puerto Rico
- Los candidatos deben tener conocimiento en PLC (el proceso de conectarse a PLC), conocer a profundidad sobre Troubleshooting (cómo identificar la señal que está llegando), sistemas de inspección, el funcionamiento del sistema de Visión y resolver problemas técnicos.
- Un "plus" en evaluaciones: conocimiento en escala, sistemas de inspección, sistemas de mantenimiento (ej. Maximo), disponibilidad completa, habilidad de trabajar en equipo y trabajar con mínima supervisión.
- Requiere que la persona domine idiomas inglés y español - oral y escrito.
- Knowledge on Rockwell Automation Platform and Allen-Bradley PLCs.
- Working knowledge of pharmaceutical/biotech processes.
- Familiarity with validation processes and documentation in a highly regulated environment.
- Strong verbal communication skills in English and Spanish.
- Skills in the following areas:
- Problem solving and root cause analysis.
- Basic technical report writing.
- Basic technical presentations.
- Personal Organization.
- Dealing with and managing change.
- Technical (Equipment Specific).
- Analytical Problem Solving.
- Computer Literacy
- Knowledgeable on Rockwell Automation Factory Talk & ControlLogix PLC Platform.
- Knowledgeable on Rockwell SLC500 PLC families Controllers.
- Knowledgeable on Rockwell Automation FTView SE and FTBatch systems.
- Knowledgeable on DeviceNet technologies.
- Work schedule flexibility to support 24/7 operations.
- Knowledge in programming language (e.g. VBA, SQL).
- Knowledge in vision system technology.
- Knowledge in serialization process.
- Basic Knowledge in robot or cobot programming.
- Verbal communication
- Written Communication/Technical Writing
- Organization
- Facilitation
- Dealing with and managing change
- Comprehensive understanding of validation protocol requirements
- Technical (Equipment Specific)
- Analytical Problem Solving
- Project Management & Planning
- Scheduling
- Computer LiteracyWork Methodology: * 100% on-site job
- Full time opportunity
- Shift: 5:00 am to 5:30 pm or 5:00pm to 5:00am; including alternate weekend
- Professional services or Temporary contract
- Rango de salario disponible $35-40 por hora - servicios profesionales.