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:
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 onmanual and automated testing of software applications, including functional, regression, and performance testing
+ Document and report defects and issuesidentifiedduring testing, and work with development teams to resolve them
+ Maintain detailed documentation of test/validation plans, test cases, and test resultsaligned toStandards 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
+ Performor supportInstallationQualification, Operational Qualification, and PerformanceQualificationvalidation on processes, equipment, and systems in conjunction with suppliers as appropriate
+ Configure andmaintainservers and applications to ensure their reliability and performance
+ Implement andmaintainsecurity measures to protect systems from unauthorized access, vulnerabilities, and other threats
+ Providean escalation-point fortechnical 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
+ Managedisasterrecovery processes to ensure dataand systems areprotected and can be restored quickly in case of a failure
+ Work closely withimplementationand project deliveryteam-members toensure delivery of new features, functionality, and releasesis performed in a manner thatprioritizesbusiness continuity and compliance withstandard procedures
Basic Qualifications and Experience:
+ Master’s degree OR Bachelor’s degree with 8 – 13 years of experience inInformation SystemsAdministration/Support/Validation
Functional Skills:
**Must-Have Skills :**
+ Excellent communication skills and the ability tointerface withsenior leadership with confidence and clarity
+ Experience withGxPregulatedcomputer systemvalidation
+ Proficiencyinthesupport and management of businessapplications, both Commercial off the shelf and custom-built.
**Good-to-Have Skills:**
+ Experience with Agile software development methodologies (Scrum)
+ Understanding ofbiostatistical analysismethods
+ Experience withgenerativeartificial intelligence, agentic AI,and other emerging technologies
Professional Certifications :
+ Scaled Agile Framework (SAFe)certification (preferred)
+ AWScertificationsincludingcloud practitioner/solutions architect/sysops administrator (preferred)
Soft Skills:
+ Strong verbal and written communication skills
+ Excellentunderstanding and adherence tostandard operating procedures
+ Excellentanalytical 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.
