Maintenance Technician II - Day and Night Shifts

Summary:
The Maintenance Technician II, under the supervision of the Facilities Maintenance Supervisor or designated supervisor, will perform various maintenance, utilities operations, and equipment support tasks for the Texas Biological Facility (TBF), Flexible Biological Facility (FBF), and National Center for Therapeutic Manufacturing (NCTM). This role includes responsibilities for maintaining utilities, facilities, and biotech processing equipment, ensuring optimal performance and minimal downtime. Adherence to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and Quality Standards in a pharmaceutical manufacturing environment is essential. This position offers opportunities for both day and night shifts, following an appropriate training period.

Functions:

• Utilities Support:
• Provide maintenance, reliability, and operational support for clean utilities, including clean gases, steam-generated Water for Injection (USP), clean steam systems, and RODI water systems.
• Maintain plant utility equipment such as air compressors, air dryers, steam boilers, chillers, heating hot water boilers, HVAC systems, and waste disposal systems.
• Biotech Equipment Maintenance:
• Support fermenters, bioreactors, tanks, chromatography columns, filtration skids, centrifuges, autoclaves, and agitators in collaboration with manufacturing operators and support teams.
• Facilities Support:
• Conduct maintenance and operational support for facilities, building infrastructure, and grounds.
• Oversee critical environment controls and maintain laboratory equipment within GMP clean rooms and controlled environments.
• Troubleshooting and Compliance:
• Perform troubleshooting and reliability tasks for temperature-controlled equipment such as refrigerators, freezers, ultra-low temperature freezers, and cold rooms.
• Ensure strict compliance with cGMP, FDA regulatory guidelines, and internal quality protocols.
• Documentation and Procedures:
• Assist in writing and revising SOPs, Job Hazard Analyses (JHAs), and preventive maintenance procedures for utility and biotech systems.
• Accurately document and execute work orders and maintenance tasks with minimal supervision.
• Collaboration and Improvement:
• Coordinate with contractors, engineers, validation teams, and quality control personnel for system improvements.
• Participate in continuous learning to enhance system knowledge and maintenance skills.
• General Duties:
• Maintain mandatory training compliance and demonstrate a professional, customer-oriented attitude.
• Perform additional tasks as assigned.

Shift Availability:

• Day Shift: Maintenance operations during regular daytime hours.
• Night Shift: Maintenance operations during nighttime hours following training.

Required Skills & Abilities:

• Advanced knowledge of mechanical and electrical principles, with strong mechanical skills for equipment listed under Essential Functions.
• Ability to use technical manuals, online resources, and P&IDs for troubleshooting and procedure development.
• Knowledge of NFPA 70E safe work practices, FDA, OSHA, EH&S, EPA, and Texas regulatory requirements.
• Proficient in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
• Strong written, verbal, and interpersonal communication skills.
• Problem-solving expertise and ability to work effectively with minimal supervision.

Qualifications:

• High School Diploma or GED with four (4) years of relevant maintenance work experience in a bio-pharma facility; OR
• Associate’s Degree in Engineering, Maintenance, Bio-Engineering, or a related field with two (2) years of relevant maintenance experience in a bio-pharma facility.

Preferred Qualifications:

• Experience in a maintenance or mechanical role within a manufacturing facility.
• Familiarity with clean room construction and functionality in bio-pharma settings.
• Additional trade experience (e.g., electrician, HVACR, boilers, pump maintenance).
• Knowledge of computerized instrumentation, microprocessor-controlled systems, and measurement tools.
• Understanding of bio-medical and bio-technical equipment (upstream and downstream processes).