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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Associate Manufacturing – Manufacturing Support Team

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will directly support Amgen’s pipeline of clinical drug product supply to patients across the globe. The Associate Manufacturing – Manufacturing Support Team (MST) role offers an opportunity to collaborate with multiple functions (Quality Assurance, Quality Control, Engineering, Facilities & Maintenance, Process Development, etc.) within the Thousand Oaks site on a routine basis in a dynamic environment.

The Associate Manufacturing – MST position is a dual-purpose role responsible for providing component and equipment preparation in support of FDA regulated manufacturing areas as well as facility/equipment cleaning and sanitation. Equipment used in the area includes autoclaves, oven, and multiple automated equipment washers. All work tasks are completed by aligning with Standard Operating Procedure's (SOP's), Current Good Manufacturing Practices (cGMP's) and Amgen regulations.

The role will require early starting hours, ranging from 2:00 am to 7:00 am, depending on training level and department needs.

Responsibilities include:

• Prepare/assemble equipment and components for use in manufacturing areas
• Operation of autoclaves, depyrogenation oven, and filter integrity testers.
• Equipment and parts cleaning using manual and automated methods.
• Perform the cleaning/sanitization of the manufacturing areas and equipment
• Assist the team with maintaining an up-to-date working inventory for the equipment/supplies
• Document and review appropriate paperwork, daily logs, files, and work order documentation per Good Documentation Practices.
• Complete work in accordance with Code of Federal Regulations (CFR's), cGMPs, SOPs, and Amgen policies
• Plan and schedule department work activities with production staff to minimize impact to production activities
• Develop, revise, and update relevant SOPs and other controlled documents
• Assist in the evaluation of the current cleaning procedures/equipment and recommend changes to optimize the cleaning program

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The Biotech/Pharma Manufacturing professional we seek is a collaborative team-player with these qualifications.

Preferred Qualifications:

• Ability to read and interpret SOP's and other documentation
• Experience with autoclaves and automated washers.
• 2 or more years of experience on Environmental Support Team (Facility Cleaning and Sanitization)
• Professional work experience in a fast-paced, flexible GMP environment
• Ability to work in an environment where cleaning products are used (i.e., bleach, isopropyl and other disinfectants)
• Ability to communicate, collaborate and be accountable
• Proficient in Microsoft Word, Excel and Outlook
• Perform moderately physical activities for up 2-3 hours and the ability to lift 25 lbs.
• Experience in document revision
• Exposure to Operational Excellence initiatives including Lean Manufacturing and 5S
• Proven written and oral communication skills and ability to balance priorities effectively
• Ability to be flexible and adaptable to support business needs
• Exposure to regulatory agency inspectors

Basic Qualifications:

Bachelor’s degree OR Associate’s degree and 4 years of Manufacturing Facilities/Environmental experience OR 2 years in a technical school setting with hands-on experience OR High school diploma / GED and 6 years of Manufacturing Facilities/Environmental experience

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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