Senior Associate Facilities

Amgen•Thousand Oaks, CA
•$90,126 - $121,936

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 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.

Requirements

  • 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

Nice To Haves

  • 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 with intermediate to sophisticated computer and typing skills

Responsibilities

  • 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

Benefits

  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
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