Validation Engineer I

ithin them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Validation Engineer I

What you will do

Let's do this. Let's change the world. 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.

The role also leverages 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.

• 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• 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

• Experienced in GxP validation process

• Have 4-5 years of experience in the Pharmaceutical Industry

• 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 the development of a modern web application

• Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, and Annex 11.

• Proficiency in automation tools, data systems, and validation software.

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:

• Able to work under minimal supervision

• Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work

• 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

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.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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