Sr. Associate Manufacturing Systems

FITS LLC; Juncos (PR); Hybrid; USD 55,000 - 85,000; Full time

Job summary

FITS LLC in Juncos, Puerto Rico, is seeking an engineer to support pharmaceutical and regulated industry operations. The role covers multi-department collaboration, equipment maintenance, regulatory compliance, and continuous improvement in process and cleaning procedures.

You will evaluate utility systems, calibration and electrical systems, manage training, and assist with inspections by FDA and other agencies. Bilingual English/Spanish, PM skills, and a degree are required.

Qualifications

• Bachelor's Degree with two years of experience as an Engineer in pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills required.
• Shift: Administrative and according to business needs.
• Experience in recipe entry on packaging equipment, validation protocol requirements, Systech/parameters, and automation assessments.

Responsibilities

• Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with industry, regulatory, and FDA standards.
• Ensure maintenance team training programs, standard operating procedures, and equipment standards are consistent.
• Coordinate technical support on engineering, regulatory, compliance, calibration, quality, environmental, and validation issues.
• Assist maintenance team during FDA and regulatory inspections and provide technical support.
• Assist with investigations of high purity water systems and environmental monitoring alerts/actions.
• Develop and maintain an audit program for the maintenance team and facilitate routine audits.
• Assist plant engineering in evaluating and implementing engineering improvements and policy changes.

Skills

Bilingual (English & Spanish)

Project Management

Regulatory industry experience

Shift: Administrative

Experience in packaging equipment

Validation protocol requirements

Systech Systems

Automation assessments

Education

Bachelor's Degree

Tools

Systech Systems

Job description

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?