Career Category

Information Systems:

Job Description

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description:

In this crucial role on the Amgen Manufacturing Systems team, you will support GxP systems validation for manufacturing facility. Specifically, this role has responsibility for generating and updating documents such as the site’s Computer/Information Systems Validation Master Plan, validation plans, system qualification protocols/reports, among others.

• Provide technical support and domain expertise for commissioning, qualification, and validation maintenance activities

• Collaborate with system owners for commissioning and qualification of manufacturing digital systems

• Coordinate actions with Manufacturing, Engineering, Quality, and Supply Chain business to ensure that the overall Amgen validation requirements are met

• Furnish technical assistance for regulatory filings, audits, and inspections

• Support deviation creation, analysis and closures

• Ensure maintenance of validation documents, validation master plan and routine monitoring of validation status/regulatory compliance of systems

• Support site/network validation driven continuous improvement initiatives

Basic Qualifications:

• Master’s degree and 3 years of Validation or Engineering experience

OR

• Bachelor’s degree and 5 years of Validation or Engineering experience

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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.

• Proficient technical writing and presentations skills so as to collaborate with technical and senior management staff

• Expertise in information systems qualification for manufacturing facility

• Extensive experience in reviewing/approving validation protocols and reports in support of facility/information systems commissioning, qualification, and change administration

• Involvement in technical implementation of validation tasks associated with core and advanced information digital systems

• Experience with SAFe and traditional Agile methodology coupled with strong GxP experience

• Knowledge of Regulations FDA Title 21 CFR Part 210 and 211

• Knowledge of AI and how to support in GxP environment

• Participation in supporting regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plans

Work Hours: This position requires you to work a later shift and may be assigned a second or third shift schedule to support east coast time (e.g. Amgen Ohio). Candidates must be willing and able to work during evening or night shifts, as required. Potential Shifts (subject to change based on business requirements): Second Shift: 2:00pm – 10:00pm IST; Third Shift: 10:00 pm – 7:00 am IST.

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 with 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.

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