Validation Engineer, R&D Precision Medicine Team

The Validation Engineer is responsible for planning and executing the testing activities for software applications and solutions that meet business needs and ensuring the availability of critical systems and applications. This role is for a senior tester with experience testing data management solutions and data analytics products, and with experience with designing and executing testing for GxP validated systems. The role involves working closely with product managers, designers, and other engineers to test high-quality, scalable software solutions.

Roles & Responsibilities:

• Participate in requirement discussions in order to create test scripts.
• Build test scripts per implementation project plan by working with various members of the product team and business partners.
• Conduct informal and formal testing, consolidate all the findings and coordinate with developer(s) and business partners to resolve all the issues
• Perform regression testing to verify the changes do not negatively impact existing system functionality
• Communicate potential risks and contingency plans with project management to ensure process compliance with all regulatory and Amgen procedural requirements
• Identify and resolve technical challenges/bugs effectively
• Work closely with cross-functional teams, including product management, design, and QA, to deliver high-quality software on time
• Support the creating and implementation of automated testing frameworks to improve efficiency and consistency

What we expect of you

• We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Masters degree with 1 to 3 years of experience in Computer Science, IT or related field OR
• Bachelors degree with 3 to 5 years of experience in Computer Science, IT or related field

Must-Have Skills:

• 3 years experience in a testing role
• Knowledge of GxP software validation processes
• Experience with test management in Jira and test automation practices
• Expert sql skills for data profiling and creation of test data
• Strong experience testing analytics and data platforms
• Good Problem-solving skills - Identifying and fixing bugs, adapting to changes
• Excellent communication skills - Explaining design decisions, collaborating with teams
• Experienced in Agile methodology

Good-to-Have Skills:

• Experience in Risk-based Approach to Change Management of Validated GxP Systems
• Experience with cloud-based technologies

Professional Certifications:

• SAFE for Teams certification (Preferred)

Soft Skills:

• 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