Sr Validation Engineer

Breda - Netherlands

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

Career Category

Engineering

Job Description

If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its 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 handson responsibilities requiring you to execute testing activities generate and manage critical validation documentation and ensure clear communication across diverse crossfunctional 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.

Lets do this. Lets 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

Bachelors degree in Life Sciences or Engineering typically 5 years of relevant experience OR Masters 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.

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 crossfunctional 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.

Required Experience:

Senior IC

Career CategoryEngineeringJob DescriptionIf you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherre...