Sr. Associate Mfg. Systems- 35751

Cis-International-LLC; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Cis-International-LLC in Juncos, PR seeks a Sr. Associate Mfg Systems for full-time site work focused on engineering support and compliance with FDA standards. The role includes coordinating maintenance operations, training, and audits over a 5-month project with possible extension and potential shift coverage.

Qualifications

• Master’s or Bachelor’s with 2+ years engineering experience or equivalent mix of education and experience.
• Associate’s degree with 6 years engineering experience.
• High school diploma with 8 years engineering experience.

Responsibilities

• Evaluate utility, process maintenance, instrumentation and electrical systems for compliance with industry and FDA standards.
• Ensure training programs and SOPs are consistent across the maintenance team.
• Coordinate technical support on engineering, regulatory, calibration and quality issues.
• Assist during FDA inspections and respond to regulatory inquiries with technical input.
• Support high-purity water systems and environmental monitoring alert/action responses.
• Develop and audit maintenance program documentation to maintain compliance.
• Contribute to engineering improvements, policy changes and optimization programs.
• Test proposed sanitization and maintenance procedure changes for process and clean rooms.
• Perform any other assigned functions.

Skills

Leadership

Verbal communication

Written communication

Organization

Facilitation

Change management

Validation protocol

Technical understanding

Analytical problem solving

Project management

Scheduling

Computer literacy

Education

Master’s degree or Bachelor’s degree + 2 years engineering experience

Associate’s degree + 6 years engineering experience

High school diploma / GED + 8 years engineering experience

Tools

Systech System

Job description

SUMMARY:
In a full automation role the Sr. Associate Mfg Systems will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications and ensure that all of the maintenance team operations and activities are maintained in compliance with respect to current corporate policies, industry standards, regulatory standards and FDA standards.

FUNCTIONS:

• Evaluate and determine if 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.
• Participate in the coordination of 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.
• Assist 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.
• Assist the maintenance team when responding to high purity water systems and environmental monitoring alert/action notifications. Assist with the investigation on all alert/action notifications.
• Assist with 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.
• Assist with the testing of proposed sanitization and maintenance procedure changes and modifications for process, utility and clean room systems.
• Other functions that may be assigned.

EDUCATION:

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

PREFERRED QUALIFICATIONS:

• Experience in recipe entry in packaging equipment, automation assessment to determine the correct parameter for the recipe and experience in Systech System.

SKILLS:

• Leadership and teambuilding
• Verbal communication
• Written Communication/Technical Writing
• Organization
• Facilitation
• Dealing with and managing change
• Comprehensive understanding of validation protocol requirements.
• Technical (Equipment Specific)
• Analytical Problem Solving
• Project Management & Planning
• Scheduling
• Computer Literacy

WORK METHODOLOGY:

• Full on site job in Juncos, PR
• Full time job
• Expected project duration: 5months for the first contractwith a high possibility of extension based on performance and budget.
• Shift: Most of the time, the schedule is on the first shift starting at 6:00 a.m.; however, depending on the non-business windows, support may be required on the second shift.
• Expected hiring date: October 2026