Automation Technician

For validation services a rea.

About Flexible & Integrated Technical Services, LLC

• If you like how this sounds, then this might be the job for you.
• Bring it on!
• We pride ourselves in how we treat the most important piece of our company's puzzle: you!
• We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!).
• Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent.
• We're FITS!
• Are you the next piece?

Responsibilities

• AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Responsibility extends to multiple departments/functional areas.
• 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.

Requirements

• The Technical Part: Bachelor's Degree with two (2) years of experience as an engineer within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Recipe entry in packaging equipment.
• Validation protocol requirements Paramater and Systech Systems Automation assessments The Personality Part: Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work.
• Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible.

Benefits

• We are a Service Provider company different from the rest.

Shift

1st shift, according to business needs. 6:00 AM - 2:00 PM 2nd shift may be required when needed.