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Associate Manufacturing

2 months ago

Thousand Oaks, California, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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

Lets do this Lets change the world The Associate of Manufacturing will work in a dynamic production environment at the Amgen Thousand Oaks Drug Substance plant supporting development, clinical, and launch activities. Under general supervision, employee will perform operations in the Manufacturing area, specifically B23 Purification processes. Operations will be performed according to Standard Operating Procedures (SOPs). This Associate is responsible for hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures and perform analytical testing. Responsibilities include:

Perform and monitor critical processes Execute routine validation protocols Comply with GMP's Regularly draft and revise routine documents (e.g. MPs, SOPs, and technical reports) Initiate and own quality records, such as CAPA, and CAPA-EV. Identify and recommend improvements related to routine functions and implement after approval Basic troubleshooting Recognize and accurately report problems Direct operators on critical processes Assist in the review of documentation for assigned functions (e.g. routine area audits, batch records) Performing activities that include periods of rigorous, repetitive work Working around high-pressure systems and occasionally work around heavy equipment Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production schedule May train staff to perform hands-on tasks May act as safety representative May participate on cross-functional teams and represent manufacturing Available to work on site Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance. Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant. Demonstrate strategic problem-solving skills and champion continual improvement. Basic Qualifications: High school/GED + 2 years of manufacturing or operations work experience OR Associates + 6 months of manufacturing or operations work experience OR Bachelors Preferred Qualifications: Bachelor's degree in Science or Engineering Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc. Knowledge of Single-use-Systems CFR and Regulatory knowledge Mechanical ability/expertise Basic statistical mathematical skills Ability to interpret and apply GMP knowledge Understanding of analytical methods for manufacturing area Demonstrated technical writing capability Able to demonstrate project management skills and presentation skills Ability to understand, apply and evaluate basic chemistry, biology and physical principles Basic troubleshooting skills on production equipment Experience with Delta V Experience with lab equipment/testing ThriveWhat 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. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: 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 and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible Apply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.