Validation Engineer

Validation Engineer

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

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.

What you will do

Let's do this. Let's change the world. In this vital role is within the Product Lifecycle Management organization at Amgen Rhode Island (ARI), a large-scale mammalian cell biotech manufacturing plant that produces multiple commercial and clinical products. The team is responsible for new product introductions (NPI), product re-introductions (PRI) to Amgen Rhode Island's Manufacturing Facilities (AR5 and AR30) and managing the lifecycle of ARI's product portfolio.

The schedule for this position is Monday – Friday Admin Day Shift.

Responsibilities:

• Support validation strategy and execute validation activities for manufacturing equipment, support equipment, and utilities, including validation planning, protocol development and execution, performance qualification, equipment release, and lifecycle documentation.
• Plan and coordinate and execute equipment and system qualification activities across a range of technologies, including CIP, SIP and autoclave systems, airflow visualization studies, benchtop equipment, and supporting utilities. Apply appropriate risk- and science-based approaches based on the system and intended use.
• Serve as the validation technical expert during project planning, equipment implementation, design reviews, and change control. Interpret engineering, automation, process, and equipment design documentation to determine validation requirements and appropriate testing approaches in accordance with established procedures and standards. Develop/author Validation plans
• Generate, review, and approve validation documentation and provide validation impact assessments for changes, projects, and equipment modifications.
• Investigate technical issues and develop solutions to validation challenges of moderate complexity.
• Execute and support cleaning validation and continued cleaning verification activities.
• Maintain site cleaning acceptance criteria, including calculating maximum allowable carryover (MAC) and providing scientific justification for acceptance criteria.
• Drive continuous improvement of validation programs, procedures, and execution practices, and develop or deliver training to manufacturing staff in support of validation activities.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The adaptable professional we seek is a self-starter with these qualifications.

• High school diploma / GED and 8 years of Manufacturing and Operations experience OR
• Associate's degree and 6 years of Manufacturing and Operations experience OR
• Bachelor's degree and 2 years of Manufacturing and Operations experience OR
• Master's degree

Preferred Qualifications

• Experience working in a GMP pharmaceutical or biotechnology manufacturing environment, with exposure to upstream and/or downstream operations.
• Hands-on validation experience with manufacturing equipment, facility systems, and utilities, including equipment qualification, sterilization/steaming, cleaning validation, and performance studies.
• Strong technical understanding of…