Location: Indianapolis
Background
RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
Job Description
The Facilities Technician ensures the proper function, maintenance, and repair of equipment, systems, and infrastructure in all areas of the building. The Facilities Technician is responsible for first line response and troubleshooting of all non-process equipment supporting the GMP manufacture of Radiopharmaceuticals at the Indianapolis site.
This individual will also be responsible for direct contact and oversight of contract service providers while they are working onsite, ensuring their compliance with GMP, EHS & NRC standards, inspecting work, and generating or acquiring appropriate documentation for filing in the CMMS and other GMP systems.
Additional responsibilities may include assisting in the commissioning, qualification, and validation of new equipment, authoring and revising SOP and PM documents, supporting maintenance of the GMP manufacturing equipment, maintaining asset records and spare parts inventory in the CMMS program, and supporting the waste management and removal processes.
Job Responsibilities
- Perform routine inspections, maintenance, and repairs on facility equipment, including HVAC systems, Compressed Air, Chilled Water, Backup Generator, UPS, electrical systems, plumbing, and other utility systems.
- Troubleshoot equipment malfunctions, identify root causes, and implement corrective actions, escalating as necessary.
- Monitor the performance of critical equipment and ensure compliance with GMP standards.
- Conduct regular inspections of the facility to identify any potential maintenance issues or safety hazards.
- Ensure compliance with GMP and NRC requirements, safety regulations, and standard operating procedures.
- Assist in authoring, reviewing, and maintaining facility-related documentation, including standard operating procedures (SOPs), maintenance and calibration records, LOTO procedures, Deviation investigations, Change Control and CAPA plans.
- Escalate complex or critical issues to the appropriate vendor, warranty program, or contract service provider to ensure prompt and effective resolution.
- Operate as site contact for contract service providers, escorting and overseeing as they engage in calibration, preventative maintenance, and repair activities.
- Maintain accurate and up-to-date records of maintenance activities, inspections, repairs, and calibrations in the CMMS.
- Coordinate and prioritize maintenance activities to minimize disruptions to production schedules.
- Utilize reporting functions of CMMS to review maintenance activities for the purpose of improving equipment uptime and reducing repeat issues.
- Respond to maintenance requests and equipment failures, troubleshooting issues and implementing corrective measures.
- Maintain a working knowledge of emergency response procedures and safety protocols.
Education and Experience
- High school diploma or equivalent is required; Associate degree, technical/journeyman certification, or vocational training in facilities maintenance, electrical systems, HVAC, or other related discipline is preferred.
- 5+ years of experience in facilities maintenance or related field required.
- Experience working in a regulated industry such as radiopharmaceuticals, pharmaceuticals, biotechnology, healthcare, or medical device manufacturing is highly desirable.
- Strong understanding of Good Manufacturing Practices (GMP) guidelines, safety regulations, and compliance requirements.
- Extensive knowledge and hands-on experience diagnosing, troubleshooting, and repairing various facility systems, equipment, and utilities.
- Working knowledge of building automation or building management systems (BAS/BMS) preferred.
- Experience with computerized maintenance management software (CMMS) recommended [ex: Maximo, SAP Maintenance, CalMan, BMRAM, etc.]
Skills
- Highly motivated and organized professional able to work both independently and as part of a team
- Skilled in interpreting technical drawings, schematics, and manuals for facility systems and equipment
- Strong attention to detail
- Ability to utilize test equipment in the execution of duties, such as Volt / Ohm Meters, Current Clamps, 4-20ma Signal Generator, etc.
- Analytical and creative problem solver
- Very personable with strong communication skills
- Excellent professional ethics, integrity, and ability to maintain confidential information
Physical Requirements
- Position requires donning a variety of personal protective equipment for the safe performance of assigned duties.
- Responsibilities also include the ability to lift up to 50 lbs., walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation. May be required to sit or stand for long periods of time while performing duties.
- May need to provide on-call support or respond to emergencies after hours in the rare case that critical equipment or alarmed/monitored systems require attention.
Benefits
- Medical, Dental and Vision plans
- Life, Accidental Death, Personal Loss, and Disability
- Flexible Spending Account (FSA)
- 401(k) Retirement Plan
- Equity/stock options
- Paid Time Off
- Company paid holidays
To apply, please send CV to jobs@rayzebio.com