Validation Engineer I

4 weeks ago

Hyderabad, Telangana, India Amgen Technology Private Limited Full time
Job Description

In this vital role, you will be 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 position involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions, as well as 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 cross-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.

Basic Qualifications

- Education and Experience: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.

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