cGMP-Driven Maintenance Technician (Medical Devices)

Mykelly; Puerto Rico; On-site; USD 52,000 - 76,000; Full time

Job summary

Mykelly is seeking a maintenance technician to perform timely preventive and corrective maintenance on assigned manufacturing equipment, ensuring safe operation, quality, and regulatory compliance. You will document work, support safety and cGMP practices, and assist with troubleshooting and basic failure analysis.

This role requires an associate degree and up to two years of relevant experience. Join a team focused on maintaining equipment readiness, ethical compliance, and continuous

Qualifications

• Associate degree in Electronics, Instrumentation, or Industrial Mechanics from an accredited university or school.
• Zero to two years of related work experience in a medical device or pharmaceutical environment.

Responsibilities

• Follows equipment maintenance guidelines by performing daily equipment start-up and shutdown procedures.
• Inspects equipment daily for safety and proper operation.
• Performs corrective and preventive maintenance according to established procedures, guidelines, and current Good Manufacturing Practices (cGMP), minimizing downtime and scrap.
• Documents all work performed, including corrective maintenance and troubleshooting activities, using established records and following cGMP guidelines (e.g., MMRR, spare-parts logbook, and downtime log).
• Resolves process and equipment issues through basic structured troubleshooting and failure analysis.
• Supports validation activities by conducting special in-line test projects and executing qualification protocols.
• Performs all maintenance activities in compliance with cGMP and applicable safety regulations and policies.
• Supports engineering tests and studies by providing technical expertise and hands‑on assistance.
• Maintains technical knowledge by attending educational workshops and reviewing relevant publications.
• Contributes to team objectives by completing related tasks, protecting confidential business information, maintaining system security and data accuracy, keeping professional and technical knowledge current, ensuring compliance with applicable laws, regulations, and corporate standards, and helping maintain a safe and healthy work environment.
• Follows prescribed safety procedures and complies with federal and local laws governing waste disposal.
• Complies with Quality System Regulations (QSR), ISO standards, applicable regulations, and company procedures.
• Acknowledges and upholds the environmental policy and actively participates in environmental programs to achieve objectives and targets within the assigned area.
• Participates in developing environmental improvement projects that minimize potential negative environmental impacts from daily operations and activities.

Education

Associate degree in Electronics, Instrumentation, or Industrial Mechanics

Job description

Mykelly is seeking a maintenance technician to perform timely preventive and corrective maintenance on assigned manufacturing equipment, ensuring safe operation, quality, and regulatory compliance. You will document work, support safety and cGMP practices, and assist with troubleshooting and basic failure analysis.

This role requires an associate degree and up to two years of relevant experience. Join a team focused on maintaining equipment readiness, ethical compliance, and continuous