Sr. Associate Manufacturing Systems

fitspr; Juncos (PR); On-site; USD 60,000 - 85,000; Full time

Job summary

FITS is a service provider company delivering Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island and in the US. We pride ourselves on being flexible, family-oriented and focused on the well-being of our resources while providing top-quality talent to Pharmaceutical, Medical Device and Manufacturing clients.

Are you the next piece? We seek a validation-focused engineer who can navigate regulatory standards, manage cross-functional collaboration,

Qualifications

• Bachelor's degree with two years of experience as an engineer in pharma or regulated industry.
• Fluency in English and Spanish, with ability to communicate across teams.
• Experience with validation protocols and packaging equipment.
• Experience with regulatory and FDA standards.

Responsibilities

• Evaluate and maintain compliance for utility, process, instrumentation, calibration, and cleaning systems.
• Ensure training programs and SOPs are consistent across the maintenance team.
• Coordinate technical support on engineering, regulatory, calibration, quality, and environmental issues.
• Assist with FDA inspections and regulatory responses.
• Support high-purity water systems and environmental monitoring investigations.
• Develop and maintain an audit program for maintenance activities.
• Assist engineering in improvements and optimization programs.
• Test proposed sanitization and maintenance changes for process and clean room systems.

Skills

Project management

Bilingual (EN/ES)

Regulatory compliance

FDA standards

Validation

Recipe entry

Systech systems

Automation assessments

Pharma industry

Education

Bachelor's degree in Engineering

Tools

Systech Systems

MS Office

Job description

For validation services a area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with two(2)years of experience asa Engineerwithin the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative and according to business needs.
• Experience in:
  • Recipe entry in packaging equipment.
  • Validation protocol requirements
  • Paramater and Systech Systems
  • Automationassessments

The Personality Part:

• Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Responsibility extends to multiple departments/functional areas.
• 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.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!

Are you the next piece?