Validation Engineer - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited

We are seeking an experienced Validation Engineer to join our team supporting a GxP platform that automates regulatory filings. This role is key to ensuring compliance, driving efficiency, and fostering innovation in data validation processes. You will collaborate closely with de ...

Roles & Responsibilities: · Develop comprehensive test plans and strategies based on project specifications and requirements. · Perform manual and automated testing of software applications, including functional, regression, and performance testing. · Document and report defects ...

Role Responsibilities: · Define and execute validation plans and risk assessments · Create and review user and functional requirement documents · Maintain compliance with 21 CFR Part 11 and Annex 11 · Manage system validation lifecycle including change control · Key Deliverables: ...

Key Deliverables: · Develop and maintain validation plans and documentation · Execute validation protocols aligned with regulatory guidelines (21 CFR Part 11, Annex 11) · Support system lifecycle validation including periodic reviews and change management · Provide technical supp ...

Key Deliverables: · Create and execute IQ, OQ protocols ensuring GxP compliance · Conduct manual and automated testing for functional and performance assurance · Maintain validation documentation aligned with regulatory standards · Collaborate on continuous improvement and automa ...

Job description · Job Description: · 1. Strong hands-on FPGA Silicon validation experience · 2. Must have protocol expertise in one or more of PCIe-Gen4/5, DDR-4/5, Ethernet, Processor based subsystem. · 3. Knowledge of RISC-V processor is a plus · 4. Proven track record of plann ...

Role Description: · We are seeking a highly skilled Validation Engineer to join our team. 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 syst ...

In this vital role you will be working closely with Business collaborators, Product Owner, Business Analysts, Developers, and Testers to ensure that Validation strategy and work are produced for IT Systems. This role will be pivotal in ensuring compliance, efficiency, and innovat ...

Role- Firmware Validation Engineer · Job Description · Job Summary: We are seeking a skilled Firmware Validation Engineer with 5 to 8 years of experience to join our dynamic team. The ideal candidate will be responsible for validating firmware functionality and performance across ...

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 pro ...

Let's do this. Let's change the world. · We are seeking an experienced Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Trial Registry system. This role will be pivotal in ensuring compliance, efficiency, and innovation in the ...

In this vital role, you will support the implementation and operational management of real-world evidence platforms at Amgen, ensuring integrity and compliance of critical systems and data. The role requires close collaboration with developers, business analysts, and product mana ...

Roles & Responsibilities: · Advising clients on how to meet compliance requirements using a risk-based approach. · Develop validation documentation and standard operating procedures for various GxP applications. · Develop test protocols that thoroughly test business requirements. ...

Roles & Responsibilities: · Develop detailed test plans and strategies based on project requirements and specifications · Perform manual and automated testing of software applications, including functional, regression, and performance testing · Document and report defects and iss ...

Roles & Responsibilities: · Translate Amgen requirements into the language of the CMO · Identify and assess validation/quality risks to enable risk-based decisions · Validation document author/approver · Determine appropriate sample plans and acceptance criteria for primary and s ...

Roles & Responsibilities: · Develop comprehensive test plans and strategies based on project specifications and requirements. · Perform manual and automated testing of software applications, including functional, regression, and performance testing. · Document and report defects ...

Key Deliverables: · Develop and execute validation protocols (IQ/OQ) for GxP-compliant systems · Design automated test suites for APIs, data pipelines, and custom software · Collaborate with cross-functional teams to ensure validation and documentation compliance · Maintain valid ...

Roles & Responsibilities: · Monitor, test, and resolve issues related to case intake and case processing across multiple systems. · Work closely with internal teams, external vendors, and business partners to address dependencies and resolve bottlenecks for critical issues · Owne ...

Key Deliverables: · Develop and maintain validation plans and lifecycle documentation · Execute risk-based validation for regulated systems and applications · Support change control and continuous validation activities · Ensure compliance with GxP, 21 CFR Part 11, and Annex 11 re ...

Key Deliverables: · Develop and execute validation plans and protocols for GxP-regulated systems · Ensure system documentation complies with 21 CFR Part 11, Annex 11, and CSA guidance · Support change control, incident handling, and periodic review for validated systems · Collabo ...