Validation Engineer - West Greenwich, RI

Validation Engineer

Let's do this. Let's change the world. In this vital role 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.