Amgen Validation Engineer Jobs For BSc & MSc – Apply Online
Validation Engineer I
Location: India – Hyderabad
Job ID: R-202371
Work Location Type: On Site
Date Posted: Dec. 03, 2024
Category: Information Systems
About Amgen
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases and make people’s lives easier, fuller, and longer.
- We discover, develop, manufacture, and deliver innovative medicines to help millions of patients.
- Amgen helped establish the biotechnology industry over 40 years ago and remains at the forefront of innovation, leveraging technology and human genetic data to push the boundaries of what’s known today.
About the Role
You will play a key role in a regulatory submission content automation initiative that will modernize and digitize the regulatory submission process, positioning Amgen as a leader in regulatory innovation.
- The initiative leverages state-of-the-art technologies, including Generative AI, Structured Content Management, and integrated data, to automate the creation, review, and approval of regulatory content.
Role Description
We are seeking an experienced Va
lidation Engineer to work on a GxP platform supporting the automation of data for regulatory filings.- This role ensures compliance, efficiency, and innovation in data validation processes.
- The successful candidate will work in a small team to support continuous improvements and automation within the program.
- The role combines technical expertise, validation experience, and regulatory understanding while collaborating closely with developers and business analysts.
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 identified during testing and collaborate with development teams for resolution.
- Maintain detailed records of test plans, test cases, and test results to ensure traceability and compliance.
- Validate test scenarios against feature acceptance criteria and customer expectations.
- Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability.
- Identify opportunities to enhance testing efficiency and minimize manual efforts.
- Evaluate and adopt tools and technologies to improve automation capabilities.
- Keep validation documentation updated and aligned with GMP standards.
- Ensure strict adherence to change management processes for validated systems.
- Stay informed on industry trends, emerging technologies, and regulatory updates.
- Provide technical support in validation to optimize quality, efficiency, and cost for new and existing applications and platforms.
Basic Qualifications and Experience
- Master’s degree and 1 to 3 years of Life Science/Biotechnology/ Pharmacology/ Information Systems experience
- OR Bachelor’s degree and 3 to 5 years of Life Science/ Biotechnology/ Pharmacology/ Information Systems experience
- OR Diploma and 7 to 9 years of 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 in writing requirements for developing modern web applications.
- Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11.
- Proficiency in automation tools, data systems, and validation software.
Good-to-Have Skills:
- Expertise in a scientific domain area and related technology needs.
- Understanding of scientific software systems strategy, governance, and infrastructure.
- Familiarity with low-code, no-code test automation software.
- Technical thought leadership.
- Ability to communicate technical or complex subjects in business terms.
- Jira Align experience.
- Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology.
Professional Certifications: SAFe for Teams certification (preferred).
Soft Skills
- Able to work under minimal supervision.
- Skilled in providing oversight and mentoring team members.
- Demonstrated ability to delegate work effectively.
- Excellent analytical and gap/fit assessment 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.
Link to apply: APPLY ONLINE HERE
Keywords: Validation Engineer, Amgen, GxP, Regulatory Submission, Automation, Agile Methodologies, Life Science, Biotechnology, Pharmacology, Information Systems. Amgen Validation Engineer Jobs For BSc & MSc – Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebo
