Sr. Associate, Manufacturing Systems – GMP & Automation

ProQuality Network; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

ProQuality Network seeks a Sr. Associate Manufacturing Systems in Juncos, Puerto Rico, for a 5-month contract, to provide technical engineering support for system and equipment optimization, upgrades, replacements, and modifications.

The role focuses on maintaining compliance with corporate policies, industry standards, regulatory requirements, and FDA standards while supporting maintenance operations and inspections.

Qualifications

• Engineering degree with 2+ years of 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.
• Perform other functions as assigned.

Skills

Engineering experience

Recipe entry

Automation parameters

Systech systems

Education

Master’s degree

Bachelor’s degree + 2 years

Associate’s degree + 6 years

High school diploma/GED + 8 years

Tools

Systech systems

Job description

ProQuality Network seeks a Sr. Associate Manufacturing Systems in Juncos, Puerto Rico, for a 5-month contract, to provide technical engineering support for system and equipment optimization, upgrades, replacements, and modifications.

The role focuses on maintaining compliance with corporate policies, industry standards, regulatory requirements, and FDA standards while supporting maintenance operations and inspections.