Specialist Manufacturing

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Job description

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Specialist Manufacturing

Live

What you will do

Lets do this. Lets change the world. In this role you will support the execution of manufacturing/quality systems such as non-conformance, process validation, procedures, training, risk assessments, and new product introductions. They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. You may also serve as the primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

Responsibilities may include:

Applied Process Expertise

As a document owner, initiate, revise, and approve manufacturing procedures to ensure all procedures reflect current operations. Assess process performance by; observation of floor operations, review of performance data and provide troubleshooting support. Evaluate, plan, and implement solutions for process improvement opportunities. Assist in generation of training materials and / or in providing training on scientific or technical aspects of the process. Execute risk evaluations for new processes or changes to existing processes and issue the summary reports of these evaluations.

Process Monitoring

Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations. Provide support of timely execution of the process monitoring quarterly reports.

Non-Conformance and CAPA

Ensure that all Non-conformance are triage within the established goal. Responsible for authoring investigation reports, execution of corrective actions and managing NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Process Validation

Assist with execution of the process validation and generation of process validation protocols and reports. Support collection and analysis of process validation data.

Regulatory

May participate in regulatory inspections

New Product Introductions & Process or Equipment Modifications

Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

Change Control

As manufacturing change owner, provide assessments on CCRB records impacting the process.

Projects and Initiatives

Bring continuous improvement initiatives for cost reduction or cycle time reduction and participate in the assessment or implementation of such special projects or initiatives.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Doctorate degree

OR

Masters degree and 3 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

Or

Bachelors degree and 5 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

Or

Associates degree and 10 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

Or

High school diploma / GED and 12 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies

We are all different, yet we all use our unique contributions to serve patients.

The manufacturing professional we seek is a dynamic and flexible individual with these qualifications:

• Detailed technical understanding of bio-processing unit operations
• Skilled in performance of GMP production operations
• Regulatory knowledge and interactions
• Experience in participating and helping lead cross-functional teams
• Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, and quality
• Excellent organizational, technical writing, presentation and verbal skills.
• Project management skills
• Knowledge of control charting

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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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.

careers.amgen.com
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.