Associate Manufacturing – Manufacturing Support Team (MST)

Career Category

Manufacturing

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals 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 may require shift hours in the future, 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 unique contributions to serve patients. The Biotech/Pharma Manufacturing professional we seek is a collaborative team-player with these qualifications.

Basic Qualifications:

• High school diploma / GED and 2 years of Manufacturing Facilities/Environmental experience OR

• Associate’s degree and 6 months of Manufacturing Facilities/Environmental experience OR

• Bachelor’s degree

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

Thrive

What you can expect of us

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

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is poste