Senior Engineer-Validation, Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Senior Engineer-Validation, Manufacturing

Live

What you will do

Does the thought of building an entirely new site from the ground up excite you? Do you love cultivating sustainable systems and high performing teams? If you have a passion for talent development and want to be a part of Amgens mission to serve patients every patient every time then check out this exciting new opportunity.

Amgen, one of the worlds leading biotechnology companies is investing $550 million to build a new multi-product drug substance biomanufacturing facility in Holly Springs, North Carolina, a biomanufacturing hub known for their life sciences industry. The new plant will combine two production formats, traditional stainless steel-fed batch and single use technology. This combination of capabilities is an approach that Amgen calls FleX Batch manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability; aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgens plan to be carbon neutral by 2027.

The investment will bring approximately 355 jobs comprised of highly skilled workers that will be built on a foundation that promotes diversity, inclusion and belonging. The site will include the manufacturing plant, warehouse, central utilities, and office space. Amgen is targeting 2024 for site completion.

Lets do this. Lets change the world. In this vital role the Senior Engineer-Validation will serve as a technical lead/subject matter expert (SME) and lead the development and implementation of the Validation strategy at the Amgen North Carolina (ANC) manufacturing facility. Specifically, this role has responsibility for developing and generating documents such as the sites Validation Master Plan, validation plans, equipment qualification protocols/reports, among others. In addition, the position will be accountable for completing landmarks related to results for autoclave performance qualification, cleaning validation, and validation maintenance.

Responsibilities:

• Provide technical support and domain expertise for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities in ANC
• Collaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing process equipment
• Supply cleaning/sterilization validation expertise including generation/review/approval of cleaning related documents (e.g., cleaning characterization/inactivation reports, acceptance limits reports)
• Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure that the overall Amgen validation requirements are met
• Furnish technical assistance and represent validation for regulatory filings, audits, and inspections
• Ensure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and systems
• Support site/network validation driven continuous improvement initiatives

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications

Doctorate degree OR

Masters degree and 3 years of Validation or Engineering experience OR

Bachelors degree and 5 years of Validation or Engineering experience OR

Associates degree and 10 years of Validation or Engineering experience OR

High school diploma/GED and 12 years of Validation or Engineering experience

Preferred Qualifications

• Proficient technical writing and presentations skills so as to collaborate with technical and senior management staff
• Expertise in equipment qualification & cleaning validation (including establishing validation strategies and procedures) for biologics facility
• Extensive experience in reviewing/approving validation protocols and reports in support of facility/equipment commissioning, qualification, and change administration
• Involvement in technical implementation of validation tasks associated with cleaning validation, steaming validation (including autoclaves) and controlled temperature chambers (CTC)
• Knowledge of Regulations Eudralex Annex 15, FDA Title 21 CFR Part 210 and 211, Guidelines ASTM E2500 and ICH Q7
• Participation in supporting regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plans

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.

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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.