Associate Systems Analyst - Lab Informatics System at Amigen

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

18 May, 26

Salary

0.0

Posted On

17 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Sample Manager LIMS, ELN, Empower CDS, CSV/CSA, GxP, 21 CFR Part 11, Data Integrity, Oracle, MySQL, API Integration, SQL, AWS, Citrix Workspace, Mulesoft, Datadobi, Validation Testing

Industry

Biotechnology Research

Description

Career Category Information Systems Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Associate IS Bus Sys Analyst What you will do Let’s do this. Let’s change the world. In this vital role you will we are seeking a highly skilled Associate Systems Analyst to join our Quality Control Product team. You will be responsible for validation, and maintenance of software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. A significant part of this role includes ensuring that QC applications such as Sample Manager LIMS, ELN, and Empower CDS are implemented, configured, and maintained in compliance with Computer System Validation (CSV) / Computer Software Assurance (CSA) expectations. You will work closely with product managers, business SMEs, validation teams, and technical partners to deliver high‑quality, compliant, and scalable QC solutions, while ensuring system availability, audit readiness, and strong data integrity controls. Roles & Responsibilities: Maintain existing code and configuration: Support and maintain Quality Control applications CSV/CSA Support: Assist in developing and executing validation deliverables (risk assessments, test scripts, traceability matrices etc) aligned with GxP, 21 CFR Part 11, data integrity, and CSA principles. Documentation: Produce clear documentation for functional specs, configuration updates, validation evidence, and operational procedures to maintain system audit readiness. Collaborative Design: Work closely with team members and collaborators to understand project requirements and translate them into functional technical designs. Testing & Debugging: Contribute to unit, integration, and validation (IQ/OQ/PQ) testing activities. Troubleshoot issues in QC systems and work with validation teams to maintain compliance. Application Support: Perform system administration tasks - periodic reviews, access management, incident resolution, audit preparation, and change‑control documentation. Continuous Learning: Stay up-to-date with the newest technologies and standard methodologies, with a focus on expanding knowledge in cloud services, automation, and secure software development. What we expect of you Must-Have Skills Solid technical background, including understanding software development processes, databases, and cloud-based systems. Solid Understanding of Quality Control Platforms (Sample Manager LIMS, ELN, Empower CDS). Foundational knowledge of CSV/CSA concepts including risk‑based testing, GxP requirements, and audit readiness. Experience working with databases, data modeling and data warehousing (Oracle, MySQL). Strong understanding of testing methodologies including validation testing. Good-to-Have Skills: Understanding of Quality Control Process. Exposure to data integrity principles for QC instruments and informatics. Curiosity of modern technology domain and learning agility Experience with the following technologies: AWS (Amazon Web Services) Services (DynamoDB, EC2, S3, etc.), Application Programming Interface (API) integration and Structured Query Language (SQL), Remote desktop application access management (Citrix Workspace, Middleware Experience (Mulesoft, Datadobi). Superb communication skills, with the ability to convey complex technical concepts. Professional Certifications NA Soft Skills: Excellent analytical and problem-solving skills. Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation. Basic Qualifications: Bachelor’s degree and 2 to 4 years of Computer Science, IT or related field experience OR Masters and 1 to 3 years of experience of Computer Science, IT or related field experience What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided 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 accommodation. . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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Responsibilities

The role involves the validation and maintenance of software applications, ensuring the availability and performance of critical systems, particularly QC applications like Sample Manager LIMS, ELN, and Empower CDS, in compliance with CSV/CSA expectations. Responsibilities include supporting existing code, assisting with validation deliverables, producing documentation, and performing system administration tasks.