Facilities Technician II GMP

Position Summary:

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The GMP Facilities Tech II performs preventative and corrective maintenance on a variety of complex utility systems within Ultragenyx GMP QC laboratory and manufacturing facilities. Equipment/systems include but is not limited to HVAC systems, cold storage, compressed air and gas systems, Reverse Osmosis (RO) and Water for Injection (WFI) systems, wastewater treatment, clean steam generation, fire detection/suppression, boilers, pumps/motors, etc. The Facilities Tech II will also perform corrective and preventive maintenance on GMP lab instruments and process equipment such as bioreactors, filling machines, centrifuges, rockers, chromatography columns, autoclaves, and glass washers. With minimal oversight, the Facilities Tech II must be able to interpret drawings, wiring diagrams, and equipment specifications to effectively perform troubleshooting and repair activities.

Work Model:

Core Lab & Ops:

This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

1. Perform and document all corrective and preventative maintenance activities performed on GMP facility equipment and/or systems in accordance with GDP requirements.
2. Ensure GMP compliance with all facilities related activities including corrective and preventative maintenance.
3. Troubleshoot complex electrical and controls issues on all building systems and equipment.
4. Maintain all facility equipment and systems at optimum levels of performance, efficiency, and reliability.
5. Ensure that all facilities and maintenance activities are performed in accordance with current internal and external requirements for safety, quality, regulatory environmental, and compliance standards.
6. Execute continuous improvement projects to improve departmental performance.
7. Collaboratively work to resolve issues and improve equipment performance.
8. Always demonstrate good safety practices, including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
9. Respond to emergency service calls and resolve identified issues in a timely manner and in accordance with all safety, quality and compliance requirements.
10. Perform weekend walkthrough duties according to schedule.
11. Participate in an On-Call rotation for off hour facility emergencies.
12. Ensure that all required quality and safety training is completed on time and current.

Requirements:

Minimum of a High School Diploma, preferably a college degree, or equivalent combination of education and direct work experience

1. 3+ years of experience working in a GMP or regulated environment required.
2. Experience working for a maintenance organization in a GMP Biotech/Pharmaceutical manufacturing environment is preferred.
3. Experience with Building Management Systems (BMS) and Computerized Maintenance Monitoring System (CMMS) software is preferred.
4. Licensure in any of the following areas is preferred: Wastewater Treatment, Refrigeration/Air Conditioning, Electrician, or Plumbing.
5. Must demonstrate ability to work independently, make effective decisions, resolve technical issues, and manage time effectively.
6. Must demonstrate effective verbal and written communication and be able to effectively interact with all levels of the organization across all departments.
7. Must demonstrate the ability to work effectively in teams to achieve results.
8. Basic proficiency with Microsoft Office Products such as Word and Excel or equivalent software applications is required.

Physical Demand Requirements:

· Stand for extended periods of time with periodic stooping / bending / kneeling. · Ability to climb ladders and stairs of various heights. · Able to lift, push, pull up to 50lbs. · Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment. · Certain tasks may require use of a respirator; medical clearance will be required in advance. · Must remove all make-up, jewelry, and contract lenses while in the manufacturing environment. · Working in temperature-controlled environments (cold rooms).

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