Regulatory-Driven Technical Maintenance Engineer

Weil Group, Inc; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Weil Group, Inc. seeks a Specialist Tech Engineering to provide technical engineering support on system optimization, upgrades, replacements, and modifications, ensuring that maintenance activities comply with corporate policies, industry standards, regulatory standards and FDA standards.

You will drive training programs, SOP consistency, and equipment standards; coordinate technical support across engineering, regulatory, calibration, quality, and environmental domains; and assist during FDA

Qualifications

• Doctorate or Masters with 2+ years of engineering experience, or Bachelor's with 4+ years of engineering experience.

Responsibilities

• Ensure 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.
• Coordinate 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.
• Provide technical support for 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.
• Support the maintenance team when responding to high purity water systems and environmental monitoring alert/action notifications.
• Support the investigation on all alert/action notifications.
• Support 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.
• Evaluate sanitization and maintenance procedures.
• Propose changes to the Department Manager.
• Propose modifications for process, utility and clean room systems to the Plant Engineering Group.

Skills

Leadership

Verbal communication

Written communication

Organization

Facilitation

Change management

Validation protocol

Technical (Equipment)

Analytical problem solving

Scheduling

Computer literacy

Education

Doctorate OR Masters + 2 years of Engineering experience OR Bachelor’s in Engineering + 4 years of Engineering experience

Job description

Weil Group, Inc. seeks a Specialist Tech Engineering to provide technical engineering support on system optimization, upgrades, replacements, and modifications, ensuring that maintenance activities comply with corporate policies, industry standards, regulatory standards and FDA standards.

You will drive training programs, SOP consistency, and equipment standards; coordinate technical support across engineering, regulatory, calibration, quality, and environmental domains; and assist during FDA