Senior Manufacturing Systems Engineer: Regulatory & Compliance

Frey Consulting Group; Juncos (PR); On-site; USD 55,000 - 75,000; Part time

Job summary

Frey Consulting Group in Juncos, Puerto Rico, seeks a Sr. Associate Manufacturing Systems to support system optimization, upgrades, and maintenance operations in a regulated environment with FDA oversight.

The role focuses on compliance with corporate policies and regulatory requirements, including support during inspections and audits, and emphasizes high-purity water systems and environmental monitoring.

Qualifications

• Engineering degree with 2+ years of engineering experience in a regulated industry.
• Experience with recipe entry for packaging equipment.
• Experience assessing automation parameters to determine the appropriate settings for recipes.
• Experience with Systech systems.

Responsibilities

• Evaluate utility systems, process maintenance, instrumentation, calibration, electrical systems, and technical cleaning systems to ensure compliance with applicable standards and requirements.
• Support the maintenance team’s training programs, SOPs, and equipment/system operational standards.
• Provide technical support for engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process maintenance matters.
• Support the maintenance team during FDA and regulatory agency inspections, including responses to technical inquiries.
• Support investigations related to high-purity water systems and environmental monitoring alert/action notifications.
• Assist with the development and maintenance of the maintenance team’s audit program, including routine audits of activities, documentation, and operations.
• Support Plant Engineering with the evaluation and implementation of engineering improvements, compliance initiatives, policy changes, and optimization programs.
• Assist with testing proposed changes or modifications to sanitization and maintenance procedures for process, utility, and clean room systems.

Skills

Regulated industry experience

Recipe entry for packaging equipment

Automation parameter assessment

Systech systems

Education

Bachelor’s degree

Associate’s degree

High school diploma/GED

Tools

Systech systems

Job description

Frey Consulting Group in Juncos, Puerto Rico, seeks a Sr. Associate Manufacturing Systems to support system optimization, upgrades, and maintenance operations in a regulated environment with FDA oversight.

The role focuses on compliance with corporate policies and regulatory requirements, including support during inspections and audits, and emphasizes high-purity water systems and environmental monitoring.