Title: Sr. Associate Manufacturing Systems

Location: Juncos, Puerto Rico (Open only for Puerto Rico Residents)

Positions: 1

Contract: 5 months

Shift: Availability for 1st, 2nd, or 3rd shift based on business needs

Summary

Our client is seeking a Sr. Associate Manufacturing Systems to provide technical engineering support for system and equipment optimization, upgrades, replacements, and modifications. The role will support maintenance operations while ensuring compliance with corporate policies, industry standards, regulatory requirements, and FDA standards.

Preferred 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.

Key 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.

Education / Experience

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

Competencies & Skills

• Leadership and team building
• Verbal and written communication
• Technical writing
• Organization and facilitation
• Change management
• Understanding of validation protocol requirements
• Equipment-specific technical knowledge
• Analytical problem-solving
• Project management and planning
• Scheduling
• Computer literacy