Pharma Equipment Maintenance Specialist | PM & Documentation

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

Job summary

FITS, LLC in Puerto Rico seeks an engineering professional to manage work orders, preventive maintenance, and training documents for the maintenance team.

The role requires reading OEM manuals, ensuring cGMP and FDA regulation compliance, and coordinating with suppliers and internal teams. Bilingual Spanish/English communication is essential, with shift-based priorities per business needs on-site.

Qualifications

• Bachelor's degree in Engineering and 3 years in Pharma or Medical Device Industry.
• Ability to read and understand technical data and OEM Equipment Manuals.
• Knowledge of cGMPs and FDA regulations.
• Experience in Pharmaceutical, Medical Devices or FDA-regulated environments.
• Bilingual Spanish/English communication skills.

Responsibilities

• Manage and create work orders, preventive maintenance, and training documents for the maintenance team.
• Scope spare parts and submit applicable requests.
• Evaluate technical documentation to be included with work.
• Create and improve PM task lists for assigned equipment.
• Evaluate OEM Documentation and attach to PMs/WOs.
• Obtain necessary approvals for all types of documents.
• Support any method transfer, verification and validation protocols.
• Work with document owner to make appropriate revision.
• Contribute to the team; support everyone's efforts to succeed; maintain a positive attitude; contribute to quality and efficiency of the department.
• Assigned as deemed appropriate by management.

Skills

Bilingual Spanish/English

Technical reading

cGMP knowledge

FDA regulations

OEM manuals

Education

Bachelor's in Engineering

Job description

FITS, LLC in Puerto Rico seeks an engineering professional to manage work orders, preventive maintenance, and training documents for the maintenance team.

The role requires reading OEM manuals, ensuring cGMP and FDA regulation compliance, and coordinating with suppliers and internal teams. Bilingual Spanish/English communication is essential, with shift-based priorities per business needs on-site.