Pharma Maintenance Engineer – Compliance & Validation

Pinnaql, Inc.; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Maintenance Specialist to provide engineering support for system and equipment optimization while ensuring compliance with regulatory standards, FDA guidelines, and internal policies.

The role requires leading a maintenance team, coordinating cross-functional support, and contributing to audits, investigations, and process improvements. Bilingual English/Spanish and strong MS Office skills are essential.

Qualifications

• Bachelor’s degree in Science or related field; minimum 5 years in pharma/biotech/medical device.
• Direct experience in pharmaceutical, medical device or biotech manufacturing environments.
• Fully bilingual English/Spanish with excellent oral skills.

Responsibilities

• Ensure utilities, process maintenance, instrumentation and electrical systems meet industry and FDA standards.
• Maintain the maintenance team training program and SOPs for consistency.
• Coordinate technical support on engineering, regulatory, calibration, quality and environmental issues.
• Provide technical support during FDA inspections and regulatory reviews.
• Support audits and investigations; contribute to continuous improvement efforts.

Skills

Leadership

Teambuilding

Verbal communication

Written Communication

Technical Writing

Validation Protocols

Equipment Knowledge

Analytical Thinking

Problem Solving

Project Management

Education

Bachelor's Degree in Science or related field

Associate’s degree + 10 years experience

High school diploma / GED + 12 years experience

Tools

Maximo

SAP

Job description

Validation & Engineering Group, Inc. is seeking a Maintenance Specialist to provide engineering support for system and equipment optimization while ensuring compliance with regulatory standards, FDA guidelines, and internal policies.

The role requires leading a maintenance team, coordinating cross-functional support, and contributing to audits, investigations, and process improvements. Bilingual English/Spanish and strong MS Office skills are essential.