Sr. Mfg Systems Engineer - Automation & FDA Compliance

Weil Group, Inc; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Weil Group, Inc is seeking a Sr. Associate Mfg Systems to provide technical engineering support for system optimization, upgrades, and compliance with FDA and regulatory standards.

Responsibilities include coordinating maintenance team training, SOPs, and standards; assisting during regulatory inspections; supporting audits and engineering improvements; and addressing issues in utility, process, and clean room systems.

Qualifications

• Engineering degree with 2+ years of experience, or Associate’s degree with 6 years of Engineering experience, or High school diploma/GED with 8 years of Engineering experience.

Responsibilities

• Evaluate utility, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems for compliance with industry, regulatory, and FDA standards.
• Ensure the maintenance team training, SOPs and equipment/operational standards are consistent across the team.
• Coordinate technical support to maintenance on engineering, regulatory, compliance, calibration, quality, environmental, validation and process maintenance issues.
• Assist during FDA and other regulatory inspections; provide technical support to the maintenance team.
• Respond to high purity water systems and environmental monitoring alerts; assist investigations.
• Develop and maintain an audit program for the maintenance team and facilitate routine audits.
• Assist plant engineering in evaluating and implementing engineering improvements, policy changes and optimization programs.
• Test proposed sanitization and maintenance procedure changes for process, utility and clean room systems.

Skills

Leadership

Teambuilding

Verbal communication

Written communication

Technical writing

Organization

Facilitation

Change management

Validation protocols

Equipment knowledge

Analytical problem solving

Project management

Scheduling

Computer literacy

Education

Engineering degree requirements

Job description

Weil Group, Inc is seeking a Sr. Associate Mfg Systems to provide technical engineering support for system optimization, upgrades, and compliance with FDA and regulatory standards.

Responsibilities include coordinating maintenance team training, SOPs, and standards; assisting during regulatory inspections; supporting audits and engineering improvements; and addressing issues in utility, process, and clean room systems.