Senior Validation Lead and System Administrator – Clinical Study Design and Analysis

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: 

The Sr. Validation Engineer – Clinical Study Design and Analysis will lead the validation and operational management of business applications used in the support of the design of clinical trials at Amgen, ensuring the integrity and compliance of critical systems and data.  

This role is accountable for monitoring and advising on process adherence in system implementations and change control, ensuring critical systems maintain a validated state for business continuity. In addition, the role is responsible for the monitoring, maintenance, and reliable operation of computer systems, servers, integrations, and databases. This role involves managing cloud environments, Software-as-a-Service applications, custom-developed applications, and integrations, with a focus on safeguarding sensitive information and ensuring the uptime, performance, and security of IT infrastructure. This role collaborates regularly with key business stakeholders, project delivery team-members, application support team-members, and quality teams.  

Roles & Responsibilities:  

• Develop detailed test plans and strategies based on project requirements and specifications 

• Assure that all validation test procedures are in line with current technology, corporate, and governmental regulations 

• Lead and advise on manual and automated testing of software applications, including functional, regression, and performance testing 

• Document and report defects and issues identified during testing, and work with development teams to resolve them 

• Maintain detailed documentation of test/validation plans, test cases, and test results aligned to Standards and Standard Operating Procedures 

• Validate that test scenarios meet feature acceptance criteria and customer expectations 

• Maintain and ensure the quality of documented user stories/requirements in tools such as Jira 

• Perform or support Installation Qualification, Operational Qualification, and Performance Qualification validation on processes, equipment, and systems in conjunction with suppliers as appropriate 

• Configure and maintain servers and applications to ensure their reliability and performance 

• Implement and maintain security measures to protect systems from unauthorized access, vulnerabilities, and other threats 

• Provide an escalation-point for technical support to users, troubleshooting and resolving issues related to system access, performance, and software 

• Apply operating system updates, patches, and configuration changes as necessary 

• Maintain detailed documentation of system configurations, procedures, and change management 

• Manage disaster recovery processes to ensure data and systems are protected and can be restored quickly in case of a failure 

• Work closely with implementation and project delivery team-members to ensure delivery of new features, functionality, and releases is performed in a manner that prioritizes business continuity and compliance with standard procedures 

Basic Qualifications and Experience: 

• Master’s degree  OR Bachelor’s degree with 8 - 13 years of experience in Information Systems Administration/Support/Validation  

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Functional Skills: 

Must-Have Skills : 

• Excellent communication skills and the ability to interface with senior leadership with confidence and clarity 

• Experience with GxP regulated computer system validation 

• Proficiency in the support and management of business applications, both Commercial off the shelf and custom-built.  

Good-to-Have Skills: 

• Experience with Agile software development methodologies (Scrum) 

• Understanding of biostatistical analysis methods 

• Experience with generative artificial intelligence, agentic AI, and other emerging technologies 

Professional Certifications : 

• Scaled Agile Framework (SAFe) certification (preferred) 

• AWS certifications including cloud practitioner/solutions architect/sysops administrator (preferred) 

Soft Skills: 

• Strong verbal and written communication skills 

• Excellent understanding and adherence to standard operating procedures 

• Excellent analytical and troubleshooting skills 

• Ability to work effectively with global, virtual teams 

• High degree of initiative, task ownership, and self-motivation 

• Ability to manage multiple priorities successfully 

• Team-oriented, with a focus on achieving team goals 

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.