Lifescience jobs at Amgen as Validation Engineering
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases.
With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
JOB TITLE: Validation Engineer I
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 management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines
technical expertise, validation experience, and a strong understanding of regulatory requirements.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 GxP standards.
- Ensure strict adherence to change management processes for validated systems.
- Stay informed on industry trends, emerging technologies, and regulatory updates relevant to GxP.
- Provide expert technical support in validation to optimize quality, efficiency, and cost for developing, troubleshooting, and improving new and existing applications and platforms.
Basic Qualifications:
- Master’s degree and 1 to 3 years of Lifescience / 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
- Have 4-5 years of experience in the Pharmaceutical Industry
Preferred Qualifications:
- Experience in Clinical Trial Registry and Regulatory submission publishing systems and processes
- Knowledge of the Disclose application from Citeline and docuBridge from Lorenz
- Demonstrated 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
- Able to communicate technical or complex subject matters in business terms
- Knowledge of DevOps, Continuous Integration, and Continuous Delivery methodology
- Professional Certifications: SAFe for Teams certification (preferred)
Soft Skills:
- Works well independently with minimal supervision
- Skilled in mentoring and oversight
- Effective delegation abilities
- Strong analytical and assessment skills
- Excellent communication (verbal & written)
- Collaborates effectively with global teams
- Self-motivated with high initiative
- Manages multiple priorities efficiently
- Team-oriented and goal-focused
- Strong presentation and public speaking skills
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Keywords: Validation Engineer, GxP platform, Pharmaceutical Industry, FDA Regulations, Agile methodologies, Testing Automation, Clinical Trials, Regulatory Compliance, Lifescience jobs at Amgen
