Associate Mfg Systems Engineer I

Amgen SA; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive benefits

Discretionary annual bonus

Stock-based incentives

Job summary

Amgen North Carolina is seeking an Associate MFG Systems Engineer I to lead validation strategy, develop validation plans and master documents, and drive commissioning, qualification, and validation activities for manufacturing equipment. You will collaborate across Manufacturing, Engineering, Quality, and Process Development to ensure compliance and success.

The role emphasizes technical writing, validation expertise, and ability to manage multiple projects, with opportunities in a global

Qualifications

• Strong technical writing and presentation skills to collaborate with technical and management staff.
• Experience with validation strategies, equipment qualification, and cleaning validation.
• Ability to read P&IDs and coordinate multi-project validation efforts.
• Experience with validation tasks for cleaning, autoclaves and sterile processes.

Responsibilities

• Lead the development and implementation of the Validation Master Plan and related documents.
• Coordinate validation activities across Manufacturing, Engineering, Quality and Process Development.
• Review and approve validation protocols and reports for commissioning and qualification.
• Support continuous improvement initiatives in validation-related processes.

Skills

Technical writing

Presentations

Project management

P&IDs reading

Education

Bachelor’s degree

Associate’s degree

High school diploma / GED

Tools

Kneat

CDOCs

Laboratory Inventory Management System

Pi

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 OR
• Associate’s degree and 4 years of Manufacturing or Operations experience OR
• 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.

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 retirement or other goals, work/life balance, and career development opportunities that may include:

• 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.

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.