Sr. Associate Manufacturing Systems 35046 (Engineering Experience)
CIS International LLC
- Juncos, PR
- Autónomo
- Tiempo completo
- Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards.
- 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.
- Master’s degree or Bachelor’s degree and 2 years of Engineering experience.
- Associate’s degree and 6 years of Engineering experience.
- High school diploma / GED and 8 years of Engineering experience.
- Knowledge on PLC Systems Trobleshooting– Rockwell
- Knowledge on Vision Systems Trobleshooting/Adjustment– Cognex
- Knowledge on cGMP’s
- Knowledge on Systech Vision System Trobleshooting\Adjustments.
- Nice to have - Work experience on FDA regulated industries.
- Knowledge on basic control systems hardware.
- Leadership and teambuilding
- 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 Literacy
- Full on site job in Juncos, PR
- Full time job
- Expected project duration: 12 months for the first contract, with a high possibility of extension based on performance and budget.
- Could be assigned to any of the four shifts A, B, C and D. Availability to 5 am – 5:30 pm and/or 5 pm – 5:30 am. Weekends and overtime may also be required.
- Expected hiring date: March 2026