Career Category

Job Description

The Senior Validation Engineer position 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.

Shift: Monday – Friday Admin Day Shift

Responsibilities:

o Develop Validation plans, execute validation Performance Qualifications (PQ)

o Responsible for the following activities:

• Cleaning and steaming validation strategy for NPI and / or equipment modifications
• Clean utility validation for new or modified systems
• Validation of new MFG benchtop equipment
• Autoclave validation strategy and improvements

o Drive continuous improvements of Validation programs and processes

o Maintain the site cleaning acceptance criteria:

• Calculate the maximum allowable carryover (MAC)
• Strong proficiency with Excel
• Understanding of the calculations and their scientific basis

o Oversee equipment validation, verification, equipment release and cleaning monitoring programs:

• Execution support for these activities
• Ownership of program SOPs

o Point of contact for validation impact during project planning and development

o Assist in developing and delivering training materials to manufacturing staff to support validation activities

o Validation planning:

• Knowledge of steaming and cleaning design concepts and the ability to determine worst case cleaning and steaming paths for various equipment types
• Proficiency in interpreting automation and engineering design documents

Basic Qualifications

o Doctorate Degree

OR

o Master's Degree and 3 years of Manufacturing and Operations experience

OR

o Bachelor’s degree and 5 years of Manufacturing and Operations experience

OR

o Associate's Degree and 10 years of Manufacturing and Operations experience

High school diploma / GED and 12 years of Manufacturing and Operations experience

Preferred Qualifications

o Manufacturing experience in both upstream and downstream operations.

o Cleaning / Steaming Validation experience

o Strong project management skills.

o Technical leadership experience.

o Strong understanding of manufacturing equipment and processes.

o CFR and Regulatory knowledge, Ability to interpret and apply GMP knowledge.

o Strong analytical and experimental design skills.

o Excellent verbal and written communication skills.

#Operation21

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, or disability status.