Validation Engineer

About this role

Career Category Operations 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. 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.

Validation Engineer

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.

Basic 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 pharmaceutical/biotechnology unit operations and manufacturing equipment and processes.

• Ability to interpret engineering and automation documentation and translate equipment and process requirements into appropriate validation testing.

• Strong understanding of GMP requirements and applicable CFR/regulatory expectations, with the ability to interpret and apply regulatory principles to validation activities.

• Strong analytical and experimental design skills, with the ability to evaluate validation data and resolve technical issues.

• Strong technical writing skills, with the ability to prepare clear, accurate, and compliant validation documentation.

• Strong verbal communication and project coordination skills, with the ability to work effectively across manufacturing, engineering, automation, and quality functions.

• Ability to work independently under general direction, manage priorities, and recognize when additional technical or management direction is appropriate.

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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 reti

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