Amgen Senior Associate Facilities in Thousand Oaks, California
Amgen Thousand Oaks is looking for a Sr. Associate Facilities to provide maintenance leadership and technical expertise in support of facility equipment/systems, utility systems, and/or production suites, ensures systems operate within designed parameters. Area of responsibility may consist of multiple facilities, disciplines or clients. All work to be completed to assure minimal impact to production while complying with all cGMP guidelines and Amgen procedures.
Directing/planning/delegating of tasks to personnel in daily operations, corrective action, and preventative maintenance activities in a reliable and compliant manner. This includes, but is not limited to, Maintenance and emergency repair of all production related process equipment and facility equipment, HVAC, and utilities systems. Typical equipment would include but is not limited to autoclaves, fermenters, centrifuges, chromatography units, ultra-filtration equipment, aseptic processing equipment, HEPA filters, high purity water systems, sanitary distribution systems, steam, chilled water, chilled glycol, process gases, electrical distribution systems, EMS/BMS/USC control systems and process control systems
With assistance from Manager, oversee selection, training and evaluation, staff relations and development of staff assigned to area of responsibility in order to maintain a proficient group of technicians which can meet the needs of manufacturing
With assistance from Manager, develop and maintain an ongoing training program. Maintain training records for all staff assigned to area of responsibility.
Assist with development and maintenance of a working inventory control system for all spare parts requirements for the above listed equipment
Manage the development and revision of related Standard Operating Procedures, Job plans for area of responsibility to assure all maintenance operations have SOPs developed for them
Interact with various support departments and/or outside vendors and provide full maintenance support to meet the needs of the manufacturing groups for all related equipment for the plant
Evaluate current maintenance procedures and make appropriate changes to optimize the maintenance program. Assure all corporate change control procedures are followed and Regulatory and QA are notified prior to the changes.
Work to be completed in accordance with CFRs, cGMPs, SOPs and Amgen policies
Will participate in On-Call rotations for after-hours facility and Manufacturing support and may work outside of established shift hours upon short notice
Bachelor’s degree and 2 years of maintenance experience
Associate’s degree and 6 years of maintenance experience
High school diploma / GED and 8 years of maintenance experience
2 year technical/AA/AS degree in building maintenance, Mechanical maintenance, Plant engineering or related technical discipline
7+ years combined education and experience with 4+ years in an FDA (GMP) or comparable regulated environment
Experience with RCA facilitation and participation
Experience with RCM, TPM, or other reliability centered concepts
Experience with installation, troubleshooting, maintenance, repair and testing of HVAC, laboratory and utilities equipment
Advanced Knowledge of pneumatic, mechanical, and hydraulic fundamentals as well as advanced skills in the use of power and hand tools in the building trades such as carpentry, plumbing, and electrical
Effective oral and written communication skills
Possess a high mathematical understanding, excellent reading skills along with intermediate to advanced computer and typing skills IND15 GD15
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.