Sr. Automation Engineering

Flexible & Integrated Technical Services, LLC • Juncos, PR

1d • Onsite

About The Position

This role is for the validation services area. The ideal candidate will have a Bachelor's Degree with two (2) years of experience as an Engineer within the pharmaceutical or regulated industry. Bilingual (English & Spanish) skills are required, along with Project Management skills. The position operates on an Administrative shift and is adaptable according to business needs. Experience in recipe entry in packaging equipment, validation protocol requirements, Parameter and Systech Systems, and automation assessments is essential. The role requires a candidate with multitasking, scientific, and creative abilities, who thrives in an environment of healthy competition, teamwork, ethical conduct, and the application of the scientific method.

Requirements

• Bachelor's Degree with two (2) years of experience as a Engineer within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Experience in Recipe entry in packaging equipment.
• Experience in Validation protocol requirements.
• Experience in Paramater and Systech Systems.
• Experience in Automation assessments.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior