Senior Engineer-Drug Product Technologies - Visual Inspection

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.

Senior Engineer--Drug Product TechnologiesVisualInspection.

Live

What you will do

Lets do this. Lets change the world. In this dynamic role you will provide support for Amgens biologics drug product and process design, commercialization and lifecycle management. Responsibilities include:

• Acts as an inspection technical specialist to provide solutions when solving inspection issues.
• Collaborate with inspection teams at drug product manufacturing sites and communicates capabilities and site practices to drug product teams.
• Work with research, manufacturing, process development, quality assurance and validation departments in developing requirements and recommendations for vision system or inspection process.
• Development and Execution of Processes Characterization for inspection systems
• Establish Testing Strategies
• Design / Development of Characterization Protocols
• Technical Reports Development
• Validations, and technical reports- To support SATs/IOQ/PQ executions, document generation and challenge validations strategies.
• Risk assessments and QRAES knowledge, to support risk assessments activities.
• Conducts risk assessment for inspection operations and propose / implement appropriate CAPA.
• Identifies and implements operational opportunities for current and new inspection operations.
• Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
• Development of Validation Plans, IOQs and PQs
• Ensure that inspection operations meet applicable quality requirements applicable regulations FDA, EU & International Standards
• Assist in the development of any existing Validation program to ensure continued compliance to regulations. Update Site Validation Guidance Documents
• Assist in deviation and exception resolution and root cause analysis.
• Participate as required in project activities.
• Coordinates and prioritizes resources needed to complete tasks

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is hardworking with these qualifications.

Basic Qualifications:

• Doctorate Degree or Doctorate Degree completed by June 2019 OR Masters Degree and 3 years of Engineering and/or Operations experience OR Bachelors Degree and 5 years of Engineering and/or Operations experience OR Associates degree and 10 years of Engineering and/or Operations experience OR High school diploma/GED and 12 years of Engineering and/or Operations experience

Preferred Qualifications

• Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics, or Statistics degree. Additional experience in applied statistics or related subject area with experience in pharmaceutical development and manufacturing is a plus.
• 5 or more years Engineering experience
• Experience in cGMP manufacturing environment, knowledge of cGMPs and other worldwide regulatory requirements, and experience in regulatory inspections.
• Knowledge of inspection processes, vision systems, Knapp studies, inspection equipment qualifications, manual inspection qualifications
• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of Inspection processes
• Project management skills, including the ability to lead numerous projects and evaluate project resource requirements.
• Lead multi-functional teams to advance detailed projects to completion and influencing decisions.
• Excellent oral and written communications 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 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.

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Equal Opportunity Statement

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 a 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 an accommodation.

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.