PD Sr Engineer

amgen; Holly Springs (NC); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Flexible work models

Award-winning time-off plans

Job summary

Amgen invites applications for a PD Senior Engineer in the Flex Batch Biologics Manufacturing Facility. This role sits in the Process Development Drug Substance Technology group and participates in process validation, tech transfer, and cross-functional support for drug-substance manufacturing.

You will lead bioburden assessments, drive process validation activities, and collaborate with upstream/downstream teams to ensure compliant, scalable operations.

Qualifications

• Bachelor’s degree or higher in a biologics-related field with relevant experience.
• 10+ years of biologics process development or validation with leadership.
• Experience in Upstream/Downstream bioprocessing in cGMP environments.
• Strong analytical and problem-solving skills.

Responsibilities

• Lead bioburden assessments and advise on unit operation capability.
• Apply upstream/downstream knowledge to microbial assessments.
• Serve as process SME to support quality partners and tech transfer.
• Draft microbial impact assessments using risk-based approaches.
• Trend bioburden data and address deviations.
• Lead the generation, resolution and closure of PD deviations.
• Provide process validation support and mentor a staff engineer.
• Support process engineering teams and digital tool development.

Skills

Upstream Cell Culture

Downstream Purification

Process Validation

Bioburden Assessment

Risk Assessment

Cross-functional Collaboration

Leadership

Education

Bachelor’s degree in Biochemical/bioprocessing

Master’s degree in Bioprocessing/Related field

Doctorate degree

Associate’s degree (with experience)

Tools

Process Validation Software

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 SENIOR 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 driving PD business strategy activities and providing cross-functional tech transfer support.

• Lead 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


• Acts as manufacturing process subject matter expert to support quality partners and provides operational and engineering understanding to assess the overall capability to clear bioburden and their potential by-products


• Works cross functionally to support draft of microbial impact assessment utilizing risk-based approach.


• Perform trending of bioburden instances within manufacturing space and elevate concerning objectionable microorganisms


• Lead the generation, resolution and closure of PD 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


• Manage and mentor an engineer member


• Support ANC PD business strategy activities to improve network practice, develop digital tools, and optimize the ANC PD business operations

What 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.

Basic Qualifications:

• High school diploma / GED and 10 years of biologics process development, process engineering, or process validation experience OR


• Associate’s degree and 8 years of biologics process development, process engineering, or process validation experience OR


• Bachelor’s degree and 4 years of biologics process development, process engineering, or process validation experience OR


• Master’s degree and 2 years of biologics process development, process engineering, or process validation experience OR


• Doctorate degree
  

Preferred Qualifications:

• 5+ 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


• Independently motivated with successful ability to multi-task and work in teams


• Demonstrated leadership skills and decision-making experience


• Experience with managing


• Experience in process scale-up, technology transfers, EBRs, deviation, CAPA, and change control processes.


• Excellent 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.

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.