Let s do this. Let s change the world. In this vital role you will work on a GxP platform supporting critical integrated case management systems. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work in 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.
The role also maximizes domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated.
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.
- Ensure system compliance with regulatory requirements for data integrity, traceability, and reliability.
- Find 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 consistency to change management processes for validated systems.
What we expect of you We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications and Experience: - Master s degree and 2 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.
Must Have Skills - Experience in creating and implementing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ).
- Solid understanding of GxP regulations, specifically 21 CFR Part 11.
- Expertise in defining and performing validation strategies aligned with regulatory requirements.
- Proficiency in automation tools, data systems, and validation software.
- Experience with Agile software development methodologies (Scrum).
- Excellent communication skills and the ability to collaborate with business domain experts, technology team members, GxP Systems Quality.
- Knowledge of Software Development Life Cycle processes, including requirements, design, testing, data analysis, change control.
Good to Have Skills: - Proficiency in automation tools, data systems, and validation software (Application Lifecycle Management and/or Veeva Vault Validation Management).
- Able to communicate technical or complex subject matters in business terms.
- Jira, HP ALM experience.
Professional Certifications: - SAFe for Teams certification (preferred)
Soft Skills: - Able to work under minimal supervision.
- 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.
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.
