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
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.