About the job
Amgen is hiring a Support Analyst / BA for its Hyderabad office. The role focuses on supporting business-critical software applications, maintaining SaaS systems, resolving incidents, testing changes, and managing validation documentation.
The position involves applications such as ALM and Kneat, along with computer system validation, databases, cloud-based systems, and Good Manufacturing Practice (GMP) applications. You will work with product managers, engineers, quality assurance teams, and other stakeholders to maintain application performance and meet regulatory requirements.
This is an on-site role that requires flexibility to work evening or night shifts, including a possible second-shift schedule. Applicants must meet the education and experience requirements specified for their qualification.
What You’ll Do
- Support and maintain SaaS applications, including ALM and Kneat, to keep systems running reliably.
- Maintain existing application code and configurations, and help develop, test, and deploy changes with guidance from senior team members.
- Write and maintain technical documentation for application features and system changes.
- Assist with unit testing, integration testing, debugging, and resolving application defects.
- Monitor application health and handle periodic reviews, incident response, troubleshooting, and security reviews.
- Prepare and review computer system validation documents and other validation records.
- Maintain documentation and processes in line with 21 CFR Part 11, EU Annex 11, and other applicable requirements.
- Support change control activities for validated computer systems.
- Work with product management, design, engineering, and QA teams to deliver and maintain reliable software solutions.
What You Need
- A Master’s degree in Computer Science, Information Technology, or a related field, with 1–3 years of relevant experience; OR
- A Bachelor’s degree in Computer Science, Information Technology, or a related field, with 3–5 years of relevant experience; OR
- A Diploma in a relevant field, with 7–9 years of relevant experience.
- A solid understanding of software development processes, databases, and cloud-based systems.
- Experience implementing Computer Software Assurance (CSA) guidance and validating computer systems.
- Experience with SQL or NoSQL databases.
- Knowledge of software testing methods and application troubleshooting.
- Previous experience supporting GMP applications.
- Strong analytical, problem-solving, documentation, and communication skills.
- Ability to work with global teams, manage competing priorities, and work independently when required.
- Willingness to work evening or night shifts according to business requirements.
Preferred Qualifications
- Basic knowledge of Veeva Validation Management, ALM, or Kneat.
- Understanding of SaaS application administration, change control, incident management, and document management.
- Ability to explain technical issues clearly to technical and non-technical stakeholders.
Technical and Regulatory Knowledge
- Application support: SaaS administration, incident resolution, application monitoring, and troubleshooting.
- Databases: SQL and NoSQL fundamentals.
- Computer system validation: CSA guidance and validation documentation.
- Regulatory compliance: 21 CFR Part 11, EU Annex 11, and GMP application support.
- Testing: Unit testing, integration testing, and debugging.
- Application tools: ALM, Kneat, and Veeva Validation Management knowledge is beneficial.
Before You Apply
- Make sure your education and experience match one of the three qualification routes specified by Amgen.
- Highlight hands-on experience with application support, computer system validation, or GMP systems.
- Include relevant work with SQL or NoSQL databases, software testing, and cloud-based applications.
- If you have used ALM, Kneat, or Veeva Validation Management, describe the tasks you performed with these tools.
- Review your experience with validation records, change control, incident management, and regulatory documentation.
- Confirm that you can work the required evening or night shifts.
Job Details
Skills
Prepare for this exact job
JobFit creates a job-specific prompt using the details from this job listing. Copy the prompt to your preferred AI assistant with your resume or profile to check your fit, tailor your resume, prepare for the interview or write a cover letter.
Preparing your job-specific prompt...
JobsInHyd is a job discovery platform and is not the employer or recruiter for this position. Job details are sourced from the original application source and may change. Please verify the latest information before applying.
JobsInHyd does not guarantee hiring outcomes.About Amgen
Amgen is a biotechnology company that develops medicines for serious illnesses. Its operations include research, manufacturing, quality, and technology functions that support the development and delivery of medicines.
Amgen is hiring a Support Analyst / BA for its Hyderabad office. The role focuses on supporting business-critical software applications, maintaining SaaS systems, resolving incidents, testing changes, and managing validation documentation.
The position involves applications such as ALM and Kneat, along with computer system validation, databases, cloud-based systems, and Good Manufacturing Practice (GMP) applications. You will work with product managers, engineers, quality assurance teams, and other stakeholders to maintain application performance and meet regulatory requirements.
This is an on-site role that requires flexibility to work evening or night shifts, including a possible second-shift schedule. Applicants must meet the education and experience requirements specified for their qualification.
What You’ll Do
- Support and maintain SaaS applications, including ALM and Kneat, to keep systems running reliably.
- Maintain existing application code and configurations, and help develop, test, and deploy changes with guidance from senior team members.
- Write and maintain technical documentation for application features and system changes.
- Assist with unit testing, integration testing, debugging, and resolving application defects.
- Monitor application health and handle periodic reviews, incident response, troubleshooting, and security reviews.
- Prepare and review computer system validation documents and other validation records.
- Maintain documentation and processes in line with 21 CFR Part 11, EU Annex 11, and other applicable requirements.
- Support change control activities for validated computer systems.
- Work with product management, design, engineering, and QA teams to deliver and maintain reliable software solutions.
What You Need
- A Master’s degree in Computer Science, Information Technology, or a related field, with 1–3 years of relevant experience; OR
- A Bachelor’s degree in Computer Science, Information Technology, or a related field, with 3–5 years of relevant experience; OR
- A Diploma in a relevant field, with 7–9 years of relevant experience.
- A solid understanding of software development processes, databases, and cloud-based systems.
- Experience implementing Computer Software Assurance (CSA) guidance and validating computer systems.
- Experience with SQL or NoSQL databases.
- Knowledge of software testing methods and application troubleshooting.
- Previous experience supporting GMP applications.
- Strong analytical, problem-solving, documentation, and communication skills.
- Ability to work with global teams, manage competing priorities, and work independently when required.
- Willingness to work evening or night shifts according to business requirements.
Preferred Qualifications
- Basic knowledge of Veeva Validation Management, ALM, or Kneat.
- Understanding of SaaS application administration, change control, incident management, and document management.
- Ability to explain technical issues clearly to technical and non-technical stakeholders.
Technical and Regulatory Knowledge
- Application support: SaaS administration, incident resolution, application monitoring, and troubleshooting.
- Databases: SQL and NoSQL fundamentals.
- Computer system validation: CSA guidance and validation documentation.
- Regulatory compliance: 21 CFR Part 11, EU Annex 11, and GMP application support.
- Testing: Unit testing, integration testing, and debugging.
- Application tools: ALM, Kneat, and Veeva Validation Management knowledge is beneficial.
Before You Apply
- Make sure your education and experience match one of the three qualification routes specified by Amgen.
- Highlight hands-on experience with application support, computer system validation, or GMP systems.
- Include relevant work with SQL or NoSQL databases, software testing, and cloud-based applications.
- If you have used ALM, Kneat, or Veeva Validation Management, describe the tasks you performed with these tools.
- Review your experience with validation records, change control, incident management, and regulatory documentation.
- Confirm that you can work the required evening or night shifts.