What are the responsibilities and job description for the Sr Associate Facilities position at Amgen?
Sr. Associate Facilities provides 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.
Responsibilities include :
Directs / plans / delegates 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.
Maintains Level 1, 2 and 3 assets including asset classification, new asset incorporation and other asset data utilizing CMMS (Maximo) in accordance with Amgen SOPs and Policies.
Assists with development and maintenance of a working inventory control system for all spare parts requirements for all Level 1, 2 and 3 assets.
Manages 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.
Interacts 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
Evaluates 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.
Ensure work to be completed in accordance with CFRs, cGMPs, SOPs and Amgen policies
