Amgen Senior CQV Engineer in Breda, Netherlands
Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. We provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and pioneering spirit that marked our early days as a biotechnology innovator.
At Amgen Breda medicines are labelled, assembled, stored and shipped to various countries. Every day more than 600 people in the Netherlands are working on supply chain processes, engineering, marketing and sales of our medicines and clinical research into new medicines.
We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this:
Senior CQV Engineer
As Senior Commissioning, Qualification & Validation Engineer you are responsible for the validation of new products, new secondary packaging technology and cold chain activities within the Amgen Breda organization. You will implement and qualify new technology for commercial release and new products prior to market release.
You will be implementing and optimizing the Commissioning, Qualification and Validation (CQV) process to ensure more effectiveness throughout the organization. This means you will be guiding and training people from other departments and getting everybody aligned with the new processes. The increasing global collaboration is a trend to be considered in this position. You will transfer validation expertise, establish validation strategies for projects and changes, generate, review and approve validation documentation and you will assist in the execution of validation at the Amgen Breda site.
What are the key-responsibilities?
Lead the CQV efforts associated with new product or technology introductions;
Provide validation impact assessment for change requests;
Work with other disciplines in developing requirements and strategies for large and/or highly complex process, system and facility modifications;
Develop solutions to complex problems requiring the use of ingenuity and creativity while maintaining compliant with regulatory and Amgen's requirements;
Apply knowledge of CQV engineering principles and practices outside of area of expertise to broad variety of assignments in related fields;
Work with project managers to complete the CQV responsibilities of projects within schedule, budget and quality constraints;
Supervise, coordinate and review work of a small staff of engineers and/or technicians on a project basis;
Ensure CQV process at the site is developed according to Corporate and GMP requirements and procedures reflecting process are in place and effective;
Integrate advanced validation engineering techniques ensuring alignment with industry standards;
Develop and provide Validation Training;
Act as Validation contact in corporate and regulatory inspections, as needed;
May act as the CQV process owner (incl. Validation contact during inspections, validation documents and training ownership).
Bachelor or master’s degree in Mechanical Engineering, Computer Science or equivalent;
Typically, 5 years of related professional experience in a role as CQV Engineer, Validation Engineer, Commissioning Engineer or CSV Test Engineer;
Fluent in English;
Experience with working within a regulated environment;
Related industry experience in Manufacturing and/or Quality Assurance and a strong knowledge of Good Distribution Practices would be preferred.
What does Amgen have to offer?
As a Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients.
We offer a permanent contract within a growing international company. With an on-site gym, sports fields and in-house catering service, Amgen creates an inspiring work environment with a focus on vitality! Are you looking to develop your career? With our Career Development Program, we support our employees to reach their goals. We offer a competitive salary, including a bonus structure and fixed 13th month. Our employees are eligible for our Long-Term Incentive Program (Amgen Stock) and a collective health insurance with a monthly contribution from Amgen.
We encourage open dialogue and professional debate, and we collaborate with world-class talent and institutions around the globe. We believe in rewarding those who do rewarding work and are committed to providing careers that can help turn the tide of serious, life-interrupting illnesses.
An online assessment is part of the recruitment process.
Due to our relocation policy, for this vacancy, we can only consider candidates who reside in the Netherlands or candidates who live on a commuting distance from Amgen Breda.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.