Quality Assurance Assistant Jobs in Puerto Rico (NOW HIRING)

Job Description: Maintenance Technician

Company: OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.

OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued.

Place of Performance

CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.

Key Responsibilities

Maintenance & Calibration Execution

• Execute preventive, predictive, and corrective maintenance activities for manufacturing, laboratory, and utility equipment in a cGMP biologics manufacturing environment.

• Perform equipment calibrations according to approved procedures, schedules, and regulatory requirements.

• Document all maintenance and calibration activities accurately and contemporaneously in the CMMS, ensuring ALCOA+ data integrity.

• Support equipment commissioning, qualification, and validation activities, including FAT/SAT, IOQ, and PQ.

• Identify, troubleshoot, and resolve equipment issues and escalate complex problems as needed.

Procedure & Instruction Development (Start-Up Phase)

• Assist in the development, review, and revision of maintenance and calibration SOPs, work instructions, job plans, and controlled forms.

• Provide technical input to define preventive maintenance tasks, calibration methods, acceptance criteria, and frequencies.

• Support establishment of equipment asset hierarchies, criticality assessments, and maintenance strategies.

• Contribute to maintenance documentation supporting startup, tech transfer, and regulatory readiness.

Equipment, Utilities & Facilities Support

• Perform routine maintenance and troubleshooting of process equipment, cleanroom infrastructure, HVAC systems, and critical utilities.

• Support instrumentation, control systems, and electrical components; mechanical systems knowledge is a plus.

• Assist with spare parts identification, inventory management, and coordination with vendors and service providers.

• Ensure tools, test equipment, and calibration standards remain in a qualified state.

GMP Compliance & Quality Support

• Execute all work in compliance with cGMP, safety, environmental, and company requirements.

• Follow approved SOPs, work instructions, cleanroom gowning, aseptic practices, and safety procedures.

• Support deviation investigations, root cause analysis, CAPAs, and change control activities.

• Maintain qualified state of validated systems through proper execution and documentation.

Collaboration & Continuous Improvement

• Coordinate activities with the Maintenance Specialist, Engineering, Production, and QA.

• Support startup readiness activities including system walkdowns, equipment turnover, and punch list resolution.

• Participate in reliability, safety, and continuous improvement initiatives.

Qualifications

• Strong technical aptitude with hands-on experience in electrical, instrumentation, and/or mechanical maintenance.

• Working knowledge of preventive maintenance and calibration programs in regulated environments.

• Ability to read and interpret technical manuals, P&IDs, electrical schematics, and drawings.

• Strong attention to detail with effective documentation and communication skills.

Education & Experience

• Associate degree or technical certification in Industrial Maintenance, Electrical, Instrumentation, Mechanical Technology, or related discipline preferred.

• Minimum three (3) years of hands-on maintenance experience in pharmaceutical, biologics, biotechnology, or medical device manufacturing.

• Experience working in cGMP-regulated environments required.

• Knowledge of instrumentation, controls, and electricity preferred; mechanical knowledge is a plus.

What we offer:

• Competitive salary (DOE)

• Health, dental, and vision insurance

• Training and professional development

• Stock option program participation

Physical Requirements

• Ability to sit, stand, walk, bend, climb, and work in confined spaces as required.

• Able to lift up to 50 pounds occasionally.

• Ability to work in laboratories, cleanrooms, mechanical rooms, and manufacturing areas while wearing required PPE.

OcyonBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by law.

If you want to challenge yourself and accelerate your career, there is no better place than here with our team. Join us today.

To learn more about us, please visit our website: https://ocyonbio.com