Associate Mfg Systems Engineer I

BioSpace; Holly Springs (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Retirement plan

Bonus program

Stock incentives

Flexible work models

Job summary

Amgen North Carolina manufacturing facility seeks a technical lead/SME to develop and implement the Validation strategy. You will generate Validation Master Plans, qualification protocols, and reports, driving autoclave qualification, cleaning validation, and ongoing maintenance activities.

You will collaborate with Manufacturing, Engineering, Quality, and Process Development to ensure comprehensive validation across equipment and processes, while supporting continuous improvement and technical

Qualifications

• High school diploma / GED or higher with manufacturing/operations experience
• Associates degree with manufacturing/operations experience
• Bachelor's degree in a related field or equivalent experience
• Technical writing and presentation skills are a plus
• Experience with cleaning validation and equipment qualification is preferred

Responsibilities

• Develop and implement the Validation strategy for ANC manufacturing
• Create and maintain Validation Master Plan, validation plans, reports
• Lead autoclave performance qualification and cleaning validation landmarks
• Collaborate with Manufacturing, Engineering, Quality and Supply Chain
• Support continuous improvement initiatives in validation processes

Skills

Sample Management lifecycle

Technical writing

Kneat

CDOCs

P&IDs reading

Project management

Validation

Education

Bachelor's degree

Associates degree

High school diploma / GED

Tools

Kneat

CDOCs

Laboratory Inventory Management System (LIMS)

PI

Job description

• Support site/network validation driven continuous improvement initiatives
• Bachelors degree
• Sample Management lifecycle experience

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

What You Will Do

Lets do this. Lets 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 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.

• 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
• Associates degree and 4 years of Manufacturing or Operations experience OR
• Bachelors 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, well 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.

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.