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Senior Manager Validation Compliance Engineering

Breda, Netherlands

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:

Senior Manager Validation Compliance Engineering

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.


What you will do

Our Site Engineering team is responsible for the process development, equipment engineering and maintenance of our assets. As the Senior Manager Validation Compliance Engineering, you will be responsible for developing and implementing robust Validation, Compliance and Lean Transformation strategies within these teams. You will collaborate closely with various departments to ensure our engineering operations meet GMP compliance, quality & safety standards, and regulatory requirements. This role requires outstanding leadership skills, strategic agility, and the ability to influence partners at all levels.

Let’s do this. Let’s change the world. In this vital role you will:

  • Mentor, coach and develop your diverse team expertise in Validation, Compliance and Continuous Improvement.
  • Develop and implement an end-to-end compliance strategy focusing on safety, quality, and regulatory requirements.
  • Own and refine the Validation & Qualification strategy in collaboration with Engineering, Technical Quality Assurance (TQA), and Digital Transformation & Innovation (DTI) teams.
  • Ensure engineering operations demonstrate compliance with Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP).
  • Lead the Engineering business resilience program, including risk management initiatives, to enhance operational efficiency and continuity.
  • Drive Lean Transformation initiatives within the Engineering department to optimize processes and improve efficiency.
  • Deploy scalable strategies for new safety, quality, compliance, and validation solutions in accordance with legislation and company policies.
  • Lead and coordinate training and development plans for the Engineering team to improve skills and foster a culture of exploration and design thinking.
  • Leverage expert knowledge in Validation, Compliance, and Lean Transformation to align priorities with business goals and global industrial trends.
  • Influence key collaborators locally and globally to ensure alignment with compliance objectives and performance goals.


What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The new colleague we seek is highly motivated to join our mission and has these qualifications:

  • Masters or Bachelor's degree in Engineering, Pharmaceutical Sciences, or related field.
  • Extensive experience (8+ years) in validation, compliance, and engineering within the pharmaceutical / biotechnology industry or other GMP industry.
  • In-depth knowledge of GMP regulations, quality systems, validation & Lean Manufacturing principles (IQ/OQ/PQ) and industry best practices.
  • Proven track record of strategic leadership in driving compliance initiatives and process optimization.
  • Strong communication, organizational change and stakeholder management skills.
  • Demonstrated ability to set and achieve ambitious performance goals that drive individual and team success.


What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. Therefore, Amgen is regularly recognized as 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.
  • Focus on innovation by implementing Microsoft Copilot and other business automation solutions.
  • Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance and a collective health insurance.
  • Focus on vitality with an on-site gym, vitality program and a restaurant with healthy food.
  • Flexible work arrangement with days in the office and days from home.

Blijf op de hoogte van de laatste farma vacatures


Blijf op de hoogte van de laatste farma vacatures