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Career Category

Engineering

Job Description

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.

Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Principal Validation Engineer- Site Facilities, HVAC and Critical Utilities

What you will do

Let's do this. Let's change the world. In this vital role you will be a key expert leading the Commissioning, Qualification, and Validation (CQV) of Site Facilities, HVAC and Critical Utilities of the AML LLC - PR operations. Your work will ensure the highest standards in our manufacturing site, making a tangible impact on global health.

Specific responsibilities include but are not limited to :

• Oversee the CQV planning, execution and documentation for Facilities, HVAC and Critical Utilities : Manage complex projects involving the planning, design, construction, maintenance, and modification of critical systems. Decide the extent of validation required applying risk / science-based strategies documented through master plans, protocols technical assessments, as well as addressing exceptional conditions. Provide prompt and sound technical support for GMP operations within the Site.
• Innovate CQV for GMP Facilities, Critical Utilities and HVAC : Apply industry-wide validation knowledge to develop sound commissioning qualifications and validation approaches for our GMP facilities.
• Team Leadership : Oversee and coordinate a team of engineers and technicians, potentially supervising staff or project resources directly, fostering a culture of excellence and continuous improvement.
• Cross-Functional Collaboration : Partner with engineering, manufacturing, process development, and quality assurance teams to develop requirements for complex processes and facility modifications to ensure smooth project delivery.
• Regulatory Compliance : Ensure validation strategies and system qualification packages compliance with global regulatory requirements including but not limited to ASTM-2500E, ISO-14644, EMA GMP Annex 1, and FDA Guidelines. Participates in internal / external audits and inspections.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients! The Principal Validation Engineer professional we seek is a collaborative individual contributor leader with these qualifications.

Basic Qualifications :

Doctorate degree in Engineering and 2 years of validation experience.

Master's degree in Engineering and 4 years of validation experience

Bachelor's degree in Engineering and 6 years of validation experience

Preferred Qualifications :

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities that may include :

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.