Associate Mfg Systems Engineer I

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 87,000 - 117,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical/Dental/Vision

Stock-based incentives

Time-off programs

Flexible work models

Job summary

Amgen Inc. North Carolina is seeking an Associate Manufacturing Systems Engineer I to lead the development and implementation of the Validation strategy at the ANC manufacturing facility.

You will generate key documents like the Validation Master Plan and qualification reports, while supporting commissioning, cleaning/sterilization validation, and validation maintenance. Qualifications include a high school diploma with manufacturing experience or a bachelor’s degree; preferred are technical

Qualifications

• Technical writing and presentations skills to collaborate with technical and senior management staff.
• Ability to gain expertise in equipment qualification & cleaning validation for biologics facility.
• Experience reviewing/approving validation protocols and reports in support of commissioning and qualification.

Responsibilities

• Develop and implement the Validation Master Plan and validation plans at ANC.
• Produce and review qualification protocols/reports and autoclave validation milestones.
• Coordinate with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure Amgen validation requirements are met.

Skills

Technical writing

P&IDs reading

Project management

Education

Bachelor's degree

Associate degree

High school diploma/GED

Tools

Kneat

CDOCs

Laboratory Inventory Management System

Pi Sample Management

Job description

Career Category Engineering 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.

ASSOCIATE MFG SYSTEMS ENGINEER I

What you will do

Let’s do this. Let’s change the world.

In this vital role you 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 site’s 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. Provide support 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 Gain 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 Support site/network validation driven continuous improvement initiatives.

What we expect of you

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

Basic Qualifications

• High school diploma / GED and 6 years of Manufacturing or Operations experience
• Associate’s degree and 4 years of Manufacturing or Operations experience
• Bachelor’s degree

Preferred Qualifications

• Technical writing and presentations skills to collaborate with technical and senior management staff
• Previous experience and proficiency using Kneat, CDOCs, Laboratory Inventory Management System and Pi Sample Management lifecycle experience
• Ability to gain expertise in equipment qualification & cleaning validation (including establishing validation strategies and procedures) for biologics facility
• Ability to gain expertise 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)
• Demonstrated ability to read P&IDs
• Ability to gain expertise managing / owning multiple projects

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.

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship Sponsorship for this role is not guaranteed. 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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law. 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.

Salary Range 86,685.55USD -117,280.45 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen