Career Category
Engineering
Job Description

Senior Engineer

What you will do

Let's do this. Let's change the world. We are seeking a Senior Engineer for our Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late-stage drug product formulation and fill/finish process development for various biological modalities (large molecule, RNA, virus). The Sr. Engineer will provide technical and project leadership while integrating information generated by multi-functional teams to ensure success through the commercialization process. The candidate will need to stay ahead of the latest developments/trends in the industry and scientific community to foster innovation and to meet future business needs. The Sr Engineer will Leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to drive innovation and accelerate research, development, and testing processes to advance Amgen practices and ensure success through the commercialization process.

The Sr. Engineer will provide support for Amgen's biologics drug product and process design, commercialization and lifecycle management. The candidate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen's drug product and process development. The Sr Engineer will operate in a fast-paced, matrixed environment and collaborate successfully with colleagues within DPT and cross-functionally to develop and proceduralize lean study designs for process characterization, create and implement tools for data acquisition, analysis, and modeling, and improve operational efficiency via alignment of work across teams, and tailoring output to intended user requirements.

A successful candidate will be able to work independently, taking responsibility of projects and self-managing their work packages with appropriate communication and escalation. A successful candidate will thrive in a multi-functional team environment, adeptly collaborating and liaising with colleagues within the function, as well as partner organizations across Operations. Finally, a successful candidate will be driven to find efficient approaches to solve relevant problems and will thereby deliver value-adding and agile solutions to Amgen Process Development.

This position requires (up to 10%) travel to domestic and international sites.

Key Responsibilities:

• Plan, design, execute, and document laboratory studies related to formulation, aseptic processing, visual inspection and fill/finish process development in support of product commercialization and life cycle management
• Apply basic science/engineering skills and first principles modeling to solve technical problems
• Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management.
• Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
• Leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to drive innovation and accelerate research, development, and testing processes
• Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
• Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs.
• Ability to travel domestically and internationally up to 10% of the time.
• Conducts risk assessment for inspection operations and propose / implement appropriate CAPA.
• Identifies and implements operational opportunities for current and new inspection operations.
• Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
• Development of Validation Plans, IOQs and PQs
• Ensure that inspection operations meet applicable quality requirements applicable laws FDA, EU & International Standards
• Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Recommendations to Site Validation Guidance Documents
• Assist in deviation and exception resolution and root cause analysis.
• Participate as required in project activities.
• Coordinates and organizes resources needed to complete tasks

What we expect of you

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

Basic Qualifications:

• Doctorate Degree OR
• Master's Degree and 2 years of Engineering and/or Operations experience OR
• Bachelor's Degree and 4 years of Engineering and/or Operations experience OR
• Associate's degree and 8 years of Engineering and/or Operations experience OR
• High school diploma/GED and 10 years of Engineering and/or Operations experience

Preferred Qualifications:

• Experience that includes elements of new product development, aseptic processing, filling, manual / automated visual inspection, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments.
• Proficiency in digital technologies and automation systems related to aseptic processing and visual inspection or filling operations, including experience with data analytics, process monitoring tools, and digital process control systems.
• Comfort with data science principles, coding, process automation, statistical techniques, deep learning, machine learning, artificial intelligence, robotics, machine vision, optics and additive manufacturing
• Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Pharmaceutics or related field or Statistics degree with experience in pharmaceutical development and manufacturing.
• Knowledge of inspection processes, vision systems, Knapp studies, inspection equipment qualifications, manual inspection qualifications
• Strong skills in applying fundamental engineering and scientific principles to the design and implementation of Inspection processes
• Experience in cGMP manufacturing environment, knowledge of cGMPs and other worldwide regulatory requirements, and experience in regulatory inspections.
• Project management skills, including the ability to manage numerous projects and evaluate project resource requirements.
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion and influencing decisions
• Excellent oral and written communications skills

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.

Salary Range
115,494.60USD -156,257.40 USD