Sr. Validation Engineer

What you will do

Let’s do this. Let’s change the world. In this vital role you will be Senior 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 demonstrates 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.
• 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 alignment 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, fixing, 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. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Doctorate degree / Master's degree / Bachelor's degree and 8 to 13 years Computer Science, IT or related field

Preferred Qualifications:

Functional Skills:

Must-Have Skills

• 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 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.
• Have strong business acumen. Can demonstrate a deep understanding of pharma industry regulations and its compliance requirements
• Have excellent knowledge of submission publishing systems like Lorenz’s docuBridge application and Disclose from Citeline
• Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation and fostering the development of talent.
• Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment.
• Experience in applying technology standard process methodologies: Scaled Agile (SAFe), ITIL, etc.

Good-to-Have Skills:

• Strong knowledge of eCTD specification and highly regulated (GxP) systems
• Experience in a leadership role within a pharmaceutical or technology organization
• Extensive experience in the software development lifecycle of GxP Systems.
• Experience using and adoption of Scaled Agile Framework (SAFe)
• 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
• Strong analytical/critical-thinking and decision-making abilities.
• Ability to work effectively in a fast-paced, dynamic environment.
• Established business partnerships and IS governance practices involving senior business partners
• Broad working knowledge of key IS domains and layers

Professional Certifications (please mention if the certification is preferred or mandatory for the role):

• ITIL (preferred)
• Scaled Agile Framework (SAFe) for Teams (preferred)

Soft Skills:

• Excellent analytical and fixing 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

Shift Information:

• This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

Equal opportunity statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with 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 an accommodation.

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.

and make a lasting impact with the Amgen team.

careers.amgen.com