Sr. Validation Engineer

4 days ago

Hyderabad, Telangana, India Amgen Inc Full time
Job Description

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 issues identified during testing, and work with development teams to resolve them
- Maintain detailed documentation of test/validation plans, test cases, and test results
- Validate that test scenarios meet feature acceptance criteria and customer expectations
- Maintain and ensure the quality of documented user stories/requirements in tools such as Jira
- Provide experienced technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardizing and improving new and existing equipment
- Prepare, execute, document, and report validation protocols in line with GxPs and other regulatory requirements and standards
- Assure that all validation test procedures are in line with current technology, corporate, and governmental regulations
- Perform IQ, OQ, and PQ validation on processes, equipment, and systems in conjunction with suppliers as appropriate

Basic Qualifications:

- Masters degree with 4 - 6 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR
- Bachelors degree with 6 - 8 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR
- Diploma with 10 - 12 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience

Functional Skills:

Must-Have Skills:

- Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology
- Experience with Agile software development methodologies (Scrum)
- Excellent communication skills and the ability to interface with senior leadership with confidence and clarity
- Experience with validation solutions, including compliance and data integrity.

Good-to-Have Skills:

- Familiarity with cloud validation (AWS / Azure / GCP).
- Experience with validation solutions, including compliance and data integrity.
- Able to communicate technical or complex subject matters in business terms
- Jira Align experience

Professional Certifications

- SAFe for Teams certification (preferred)

Soft Skills:

- Able to work under minimal supervision
- Excellent analytical and troubleshooting skills
- Strong verbal and written communication skills
- Ability to work effectively with global, virtual teams
- High degree of initiative and self-motivation
- Ability to manage multiple priorities successfully
- Team-oriented, with a focus on achieving team goals
- Strong presentation and public speaking skills

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