Sr Validation Engineer

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us as:

Sr Validation Engineer

At Amgen Breda medicines are labelled, assembled, stored and eventually shipped to various countries worldwide. Every day more than 1000 people with 42 different nationalities are working on supply chain processes, manufacturing, marketing and sales of our medicines and clinical research into new medicines.

Live

What you will do

In this vital role, you will serve as a key subject matter expert in validation within the Validation & Compliance organization. This department oversees Deviations, Change Control, and Continuous Improvement for Engineering, ensuring that all processes, systems and equipment operate in full compliance with GMP, corporate standards and international regulatory requirements.

You will work across multiple disciplines to assess the impact of changes, define and shape validation strategies at site level, and lead validation activities for complex projects and change initiatives.

This role combines strategic and hands‑on responsibilities, requiring you to execute testing activities, generate and manage critical validation documentation, and ensure clear communication across diverse cross‑functional teams.

You will act as the validation SME within project environments, support audits, and hold full accountability for validation deliverables throughout the project lifecycle. The position demands strong technical judgment, autonomy, and the ability to collaborate effectively in a highly regulated environment.

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

In this vital role you will:

• Establish validation strategies for projects and site changes.
• Conduct validation impact assessments for change requests.
• Generate, review and approve validation documentation in line with GMP and corporate requirements.
• Support and oversee the execution of validation activities at ABR.
• Collaborate with cross-functional teams to define requirements and strategies for complex system, process and facility modifications.
• Develop creative and compliant solutions to complex validation challenges across multiple technical domains.
• Work closely with project managers to ensure validation deliverables meet scope, schedule and quality expectations.
• Supervise, coordinate and review the work of small teams of engineers and/or technicians on a project basis.
• Maintain and improve site validation processes, ensuring alignment with corporate standards and regulatory requirements.
• Integrate advanced validation techniques and industry standards (e.g., GAMP, ASTM E2500.
• Deliver validation training and act as a key point of contact during audits and inspections; may serve as Validation Process Owner.

Win

What we expect of you

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

The Sr Validation Engineer we seek is a strong technical leader with the following qualifications:

Basic Qualifications

• Bachelor’s degree in Life Sciences or Engineering + typically 5+ years of relevant experience OR Master’s degree in Life Sciences or Engineering + typically 3+ years of relevant experience, Fluent in English.
• Direct experience in regulated environments.
• Strong knowledge of GAMP, ASTM E2500, Annex 13, ICH Q7A, and 21 CFR Parts 11, 210, 211.

Preferred Qualifications

• Typically 10+ years industry experience in Manufacturing and/or Quality Assurance.
• Strong knowledge of GDP.
• Experience with digital/automated equipment validation.
• Background from complex system environments

Skills & Capabilities

• Broad technical knowledge within validation and related areas; understands cross‑functional dependencies.
• Strong analytical skills; ability to interpret complex qualitative and quantitative data and anticipate issues.
• Works with minimal direction and independently determines approaches for multiple projects.
• Provides coaching, training and technical guidance to others.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we work to care for our teammates’ professional and personal growth and well-being. Therefore, Amgen is regularly recognized as a Best Place To Work ©.

• Vast opportunities to learn and move up and across our global organization.
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
• Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance and collective health insurance.
• Focus on vitality with an on-site gym, vitality program and a restaurant with healthy food.