PD Engineer

Amgen; Holly Springs (NC); On-site; USD 88,000 - 119,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Generous time-off

Flexible work models

Job summary

Amgen is seeking a PD Engineer to join the Process Development Drug Substance Technology group within the PBS team at its FleX Batch Biologics Manufacturing Facility. You will contribute to process validation, tech transfer, and bioburden assessments across upstream and downstream operations to ensure compliant, scalable manufacturing of drug substances.

The role requires multiple pathways of biologics process development or validation support, strong communication, and collaboration with

Qualifications

• High school diploma / GED and 8 years of biologics process development or process validation support experience
• Associate’s degree and 6 years of biologics process development or process validation support experience
• Bachelor’s degree and 2 years of biologics process development or process validation support experience
• Master’s degree

Responsibilities

• Support bioburden impact assessment and assess unit operation capability to remove microorganisms or potential by-products and provide operational and engineering advice as part of the overall assessment
• Apply a fundamental understanding of Upstream (Cell Culture) and Downstream (Purification) bioprocessing to provide risk-based approach to microbial assessments
• Work cross-functionally to support microbial impact assessment drafts and documentation review
• Perform trending of bioburden instances within manufacturing space and elevate concerning objectionable microorganisms
• Provide guidance for the generation, resolution and closure of deviations
• Support upstream and/or downstream process engineering teams for process monitoring or technical study activities
• Provide process validation support as required for documentation or floor activities
• Support ANC PD business strategy activities to improve network practice, develop digital tools, and optimize the ANC PD business operations

Skills

Upstream (Cell Culture)

Downstream (Purification)

Process Validation

Biopharmaceutical manufacturing

cGMP compliance

Education

High school diploma / GED

Associate’s degree

Bachelor’s degree

Master’s degree

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.

PD ENGINEER

What you will do Let’s do this. Let’s change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgen’s FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes development, support, and execution of process validation. The role will be responsible for ensuring process validation activities are performed in a consistent and controlled manner to support manufacture of drug substances. In addition, the role will be responsible for early engagement tech transfer activities and PD business strategy. Support bioburden impact assessment and assess unit operation capability to remove microorganisms or potential by-products and provide operational and engineering advice as part of the overall assessment Apply a fundamental understanding of Upstream (Cell Culture) and Downstream (Purification) bioprocessing to provide risk-based approach to microbial assessments Work cross-functionally to support microbial impact assessment drafts and documentation review Perform trending of bioburden instances within manufacturing space and elevate concerning objectionable microorganisms Provide guidance for the generation, resolution and closure of deviations. Support upstream and/or downstream process engineering teams for process monitoring or technical study activities Provide process validation support as required for documentation or floor activities Support ANC PD business strategy activities to improve network practice, develop digital tools, and optimize the ANC PD business operations.

We expect of you

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

• High school diploma / GED and 8 years of biologics process development or process validation support experience
• Associate’s degree and 6 years of biologics process development or process validation support experience
• Bachelor’s degree and 2 years of biologics process development or process validation support experience
• Master’s degree

• 2+ years of experience in an Upstream (Cell Culture), downstream (purification), or process validation role supporting biopharmaceutical processes within regulated environments (i.e., cGMP)
• Strong and in-depth expertise of the operation of upstream or downstream manufacturing processes
• Experience with biopharmaceutical processes including process technical documentation, process monitoring, or large-scale studies
• Experience with bioburden impact assessments in cGMP biopharmaceutical manufacturing
• Experience in technology transfers, CAPA, and deviations
• Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders

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

Salary

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.

Salary Range 88,281.00USD -119,439.00 USD

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.

Equal Opportunity

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.

Applicant Guidance

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.

Company Overview

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