Maintenance Tech II
Kite Pharma
Summary
Kite Pharma, Inc. is an American biotechnology company specializing in cancer immunotherapy with a primary focus on genetically engineered autologous CAR T cell therapy. Founded in 2009 and headquartered in Santa Monica, California, Kite was acquired by Gilead Sciences in 2017 for $11.9 billion. The company develops cell-based therapies that reengineer a patient's own immune cells to attack and fight cancer cells, representing a personalized approach to cancer treatment. Kite's lead product, Yescarta (axicabtagene ciloleucel), was the first CAR T therapy approved by the FDA for treating adult patients with relapsed or refractory large B-cell lymphoma. With approximately 2,000 employees and manufacturing facilities in California, Maryland, and the Netherlands, Kite operates as an independent company within Gilead Sciences while maintaining its singular focus on advancing cell therapy to treat and potentially cure cancer. The company's innovative approach represents a paradigm shift in cancer treatment, moving away from traditional pharmaceutical manufacturing to individualized cell therapies created one patient at a time.
Job description
Key Responsibilities
- Performs installation, maintenance, and repairs of process manufacturing equipment.
- Provides general maintenance support including HVAC equipment (boilers, air handling units, purified water system, air compressors, product storage), welding, fabricating, construction, and light electrical installations.
- Must exhibit proficiency with the Building Management System and its controls.
- Perform monitoring of all EMS/BMS systems to ensure facilities, equipment and environmental systems are within specified ranges and operating systems are functioning properly.
- Independently locates and diagnoses failure, replaces defective components and performs basic troubleshooting using standard electronic equipment, detailed drawings, diagrams, sketches, specifications, prints, manuals and verbal and/or written instructions.
- Uses a variety of hand, power and test tools and equipment.
- Coordinates maintenance on critical systems/equipment with supervisor.
- Creates or revises standard operating procedures, and maintenance job plans.
- Complies with all safety regulations and current Good Manufacturing Practices (GMPs).
- Is required to respond to emergency notifications via phone.
- Maintain a safe work environment; work in a safe manner following all safety SOPs and wear Personal Protective Equipment as required.
- Maintain accurate records, always keeping equipment and systems cGMP compliant using Good Documentation Practices (GDP).
- Performs multi-shift work as required.
- Additional duties as assigned.
Knowledge and Skills
- Possesses an electrical acumen including understanding electrical single line diagrams, wiring diagrams, controls schematics and equipment specifications.
- Possesses a mechanical and electrical acumen including HVAC, Purified Water system, facilities utilities, P&IDs, schematics, and equipment specifications.
- Observes deviations from systems specifications and works with Facilities staff to correct or resolve these discrepancies.
- Ability to obtain gowning certification for Grade B environment.
- Ability to obtain certification for respiratory protection program.
- Ability to operate Main switchgears up to 35kV or similar.
- Control automation and PLC experience.
- EPA Universal CFC Certification.
- Ability to read blueprints, control drawings and logic controls.
- Ability to install relays and run wiring, conduits, and any light electrical work.
- Ability to use temperature and relative humidity meters, data loggers, electrical volt and amp meters.
- Self-starter with superior analysis and problem solving skills ranging from simple to complex situations.
- Be forward thinking with the ability to work with system & technical metrics, identify variances & deficiencies while improving maintenance program and performance.
- Be proficient in MS Office suite.
- Demonstrates proficiency in current Good Manufacturing Practices (GMPs).
- Possess good communications skills to explain information and influence others to secure successful implementation of Facilities and Engineering programs and directives as assigned.
- Must have a strong work ethic and demonstrate dependability and timeliness.
- Willingness to put internal customer needs first.
- Have a high energy level and a positive outlook coupled with the requisite can do attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
Basic Qualifications
- High School Diploma with at least 5 years of maintenance experience in a biotech or pharmaceutical company with direct experience with GMP facility operation.
- AAS degree with at least 4 years of maintenance experience in a biotech or pharmaceutical company with direct experience with GMP facility operation preferred.
- Exposure to operations involving engineering disciplines including Electrical, Mechanical, Process, Civil, Structural, Environmental, and Industrial.
- Able to prioritize multiple tasks/priorities and the ability to work under specific time constraints are required.
- Demonstrated understanding of systems needed to manage a GMP facility such as: HVAC, electrical, process systems, plumbing/piping, general maintenance, pest management, both interior and exterior.
- Must be able to lift, carry, push and/or pull 75 lb. of equipment or supplies.
- Must be able to stand, walk, squat, bend, kneel, climb, and or reach for 75% of a shift.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Business travel may be required.
Requirements
- High School Diploma with at least 5 years of maintenance experience in a biotech or pharmaceutical company with direct experience with GMP facility operation
- AAS degree with at least 4 years of maintenance experience in a biotech or pharmaceutical company with direct experience with GMP facility operation preferred
- Exposure to operations involving engineering disciplines including Electrical, Mechanical, Process, Civil, Structural, Environmental, and Industrial
- Able to prioritize multiple tasks/priorities and the ability to work under specific time constraints
- Demonstrated understanding of systems needed to manage a GMP facility such as HVAC, electrical, process systems, plumbing/piping, general maintenance, pest management
- Must be able to lift, carry, push and/or pull 75 lb. of equipment or supplies
- Must be able to stand, walk, squat, bend, kneel, climb, and or reach for 75% of a shift
- Ability to operate Main switchgears up to 35kV or similar
- Control automation and PLC experience
- EPA Universal CFC Certification
- Ability to read blueprints, control drawings and logic controls
- Ability to install relays and run wiring, conduits, and any light electrical work
- Ability to use temperature and relative humidity meters, data loggers, electrical volt and amp meters
- Proficient in MS Office suite
- Demonstrates proficiency in current Good Manufacturing Practices (GMPs)
- Good communications skills
- Strong work ethic and dependability
- Ability to obtain gowning certification for Grade B environment
- Ability to obtain certification for respiratory protection program
Benefits
- Discretionary Annual Bonus
- Stock-Based Long-Term Incentives
- Paid Time Off
- Medical, Dental & Vision
- Life Insurance
Company overview
Kite Pharma, Inc. is an American biotechnology company specializing in cancer immunotherapy with a primary focus on genetically engineered autologous CAR T cell therapy. Founded in 2009 and headquartered in Santa Monica, California, Kite was acquired by Gilead Sciences in 2017 for $11.9 billion. The company develops cell-based therapies that reengineer a patient's own immune cells to attack and fight cancer cells, representing a personalized approach to cancer treatment. Kite's lead product, Yescarta (axicabtagene ciloleucel), was the first CAR T therapy approved by the FDA for treating adult patients with relapsed or refractory large B-cell lymphoma. With approximately 2,000 employees and manufacturing facilities in California, Maryland, and the Netherlands, Kite operates as an independent company within Gilead Sciences while maintaining its singular focus on advancing cell therapy to treat and potentially cure cancer. The company's innovative approach represents a paradigm shift in cancer treatment, moving away from traditional pharmaceutical manufacturing to individualized cell therapies created one patient at a time.