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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.

Specialist Manufacturing - DS Major Deviations

Live

What you will do

Let’s do this! Let’s change the world! In this vital role you will have the outstanding opportunity to tackle a variety of challenges and responsibilities around our state-of-the-art Mammalian Cell Culture & Bacterial Fermentation and Purification facilities. Your responsibilities include the execution of manufacturing/quality systems such as, risk management, deviations, process monitoring & validation, process improvements, procedures, training, and new product introductions. To keep everything running efficiently, you will also be involved in applying process, operational, scientific expertise, basic compliance knowledge, analytical & troubleshooting skills to support manufacturing operations.

Specific responsibilities include but are not limited to:

• Lead major/trend deviation investigations throughout the whole lifecycle, including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring investigation reports, leading Trackwise record, speaking publicly at regulatory inspections
• Facilitate Risk Assessments and author risk assessment reports
• Own corrective/preventive action records and lead implementations.
• Assist in the generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Provide troubleshooting support and may participate in regulatory inspections.
• Participate in the New Product Introduction (NPI) process to assess requirements for documentation, materials, training, and equipment modifications.
• May lead initiatives related to training strategies to support manufacturing areas.
• Participate on the assessment or implementation of special projects or initiatives.
• Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data.
• Evaluate, plan, and implement solutions for process improvement opportunities.
• Support non-standard shift organization, including weekends and extended hours as per business needs.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Specialist Manufacturing professional we seek is an individual contributor with these qualifications.

Doctorate degree

Or

Master’s degree & 3 years of Manufacturing support experience in a GMP regulated industry

Or

Bachelor’s degree & 5 years of Manufacturing support experience in a GMP regulated industry

Or

Associate’s degree and 10 years of Manufacturing support experience in a GMP regulated industry

Or

High school diploma / GED and 12 years of Manufacturing support experience in a GMP regulated industry experience

Beyond that, additional preferred qualifications are:

• Educational background in Life Science, Chemistry, Biochemistry, Industrial Biotechnology, Bioengineering, Chemical/Biochemical Engineering and/or Mechanical Engineering
• Strong Technical Writing and verbal communication skills in English and Spanish.
• In-depth experience in Root Cause Analysis (Fishbone, Six Boxes, Fishbone, 5 Why’s, Kepner Tregoe).
• Detailed technical understanding of bio-processing unit operations.
• Compliance/Regulatory knowledge and audit interaction experience.
• Experience leading cross-functional teams for Root Cause Analysis and problem solving.
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Strong presentation and project management skills.

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 maximize 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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