Senior Validation Lead and System Administrator – Clinical Study Design and Analysis
Senior Validation Lead and System Administrator – Clinical Study Design and Analysis
India - Hyderabad Apply NowABOUT 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
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.