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Amgen
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Validation Engineer I

Validation Engineer I

Amgen

1 - 3 years

18 - 20 Lacs

Hyderabad

Posted:5 days ago| Platform:

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Skills Required

Product management Change management NoSQL Business analysis Oncology Incident management Document management Monitoring SQL

Work Mode

Work from Office

Job Type

Full Time

Job Description

Let s do this. Let s change the world. In this vital role you will responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime.

Roles & Responsibilities:

Develop and maintain Validation Plans, including scope, responsibilities, deliverables, and timelines.
Perform risk-based assessments to determine the level of validation required.
Assist in defining User Requirements and Functional Requirements.
Draft and review various validation artifacts.
Ensure all documents are compliant with 21 CFR Part 11, Annex 11, and other relevant regulations.
Coordinate and/or execute validation protocols.
Support change management processes for validated systems.
Ensure continuous validation throughout the system lifecycle (including periodic reviews).
Work closely with multi-functional teams, including product management, design, and QA, to deliver high-quality software on time.
Stay updated with the latest trends and technologies, and related fields.
Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

Master s degree and 1 to 3 years of related field experience OR
Bachelor s degree and 3 to 5 years of related field experience OR
Diploma and 7 to 9 years of related field experience
Strong technical background, including understanding software development processes, databases, and cloud-based systems.
Experience implementing CSA guidance and validating computer systems.
Experience working with databases (SQL/NoSQL).
Strong foundational knowledge of testing methodologies.

Preferred Qualifications:

Basic understanding of Veeva Validation Management/ALM/KNEAT.
Strong understanding of SaaS, MuleSoft, Change Control, Incident Management, document management.
Strong Business Analysis skills with basic Veeva configuration knowledge.
Excellent communication skills, with the ability to convey complex technical concepts.

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.

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Validation Engineer I