Senior Manager Validation Compliance Engineering

at  Amgen

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:

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.