Senior Associate Facilities

What you will do

Let’s do this. Let’s change the world. Amgen Thousand Oaks is looking for a Sr. Associate Facilities to provide maintenance leadership and technical expertise in support of Drug Substance facilities and their equipment/systems, utility systems, and/or production suites, ensures systems operate within crafted parameters. Area of responsibility may consist of multiple facilities, fields or clients. All work to be completed to assure minimal impact on production while following all cGMP guidelines and Amgen procedures.

• Advising/planning/delegating of tasks to personnel in daily operations, corrective action, and preventative maintenance activities in a reliable and compliant manner to support multiple drug substance facilities.
• This includes the planned Maintenance and emergency repair of all production related facilities components including doors, working surfaces, permanently mounted equipment, facility lighting, equipment power supplies, and storage spaces.
• Works with a group of maintenance technicians, system owners, QA, and manufacturing management to prioritize daily activities.
• Responsible for ensuring repairs that are made within clean room spaces follow GMP regulations to ensure no impact to production quality and schedule.
• Maintains an environment that promotes maintenance flexibility, consistent maintenance practices, and efficient operations.
• Assist with development and maintenance of a working inventory control system for all spare parts requirements for the above-mentioned equipment.
• Be responsible for 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 facility equipment for plant needs.
• Serve as an additional owner and SME for all water based critical utilities and support internal audits, regulatory audits and plant tours of utility spaces.
• 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.

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with the following qualifications:

• Master’s degree OR Bachelor’s degree and 6 months of maintenance experience OR Associate’s degree and 2 years of maintenance experience OR High school diploma / GED and 4 years of maintenance experience

• 2 year technical/AA/AS degree in building maintenance, Mechanical maintenance, Plant engineering or related technical field
• 6+ 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 working in dynamic environments and facilities which follow FDA/GMP regulations.
• Knowledge of pneumatic, mechanical, and hydraulic fundamentals as well as 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…