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,fullerand longer. We discover, develop,manufactureand deliver innovative medicines to help millions of patients. Amgen helpedestablishthe biotechnology industry more than 40 years ago andremainson thecutting-edgeof innovation, using technology and human genetic data to push beyondwhat’sknown today.

ABOUT THE ROLE

Role Description:

The Sr. Validation Engineer – ClinicalStudy Design and Analysiswillleadthe validation and operational management ofbusiness applicationsusedinthe support of thedesignof clinical trialsat Amgen, ensuring the integrity and compliance of critical systems and data. 

This role isaccountable formonitoringandadvising onprocess adherence in systemimplementations andchangecontrol,ensuringcritical systemsmaintaina validatedstateforbusiness continuity.In addition, theroleis responsible forthemonitoring,maintenance, and reliable operation of computer systems,servers, integrations, and databases.This role involves managingcloudenvironments,Software-as-a-Service applications, custom-developed applications,andintegrations,with a focus onsafeguarding sensitive informationandensuring the uptime, performance, and securityof IT infrastructure. This role collaboratesregularlywithkeybusiness stakeholders,project deliveryteam-members, application supportteam-members, and qualityteams.

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 

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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 toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to requestan accommodation.