Senior Engineer – Internal Process Engineering

Amgen

Senior Engineer supporting the development and optimization of drug product processes at Amgen. Collaborating with cross-functional teams and ensuring technical documentation for regulatory submissions.

Posted 4/23/2026full-timeThousand Oaks • California, Massachusetts • 🇺🇸 United StatesSenior💰 $115,495 - $156,257 per yearWebsite

About the role

Key responsibilities & impact

Join Amgen’s Drug Product Process Engineering team within the Drug Product Technologies organization
Support the development, implementation, and continuous improvement of drug product processes across Amgen’s parenteral portfolio
Contribute technical expertise to support evolving business needs, industry trends, and stakeholder priorities
Be based in Thousand Oaks, CA or Cambridge, MA to ensure effective technology transfer support
Operate in product and process development and/or manufacturing environments, supporting the design and execution of process characterization studies
Evaluate the impact of manufacturing process parameters, production scale, equipment, and raw material changes on product quality
Prepare high-quality technical documentation, including process technology transfer documents, study reports, and technical assessments
Support the development of relevant sections of regulatory submissions to enable successful introduction of new processes and/or production facilities
Work closely with clinical and commercial manufacturing teams to support ongoing production, new product introductions, new technology implementation, and process optimization efforts
Collaborate with cross-functional teams including engineering, analytical sciences, quality, regulatory, and manufacturing

Requirements

What you’ll need

Doctorate degree
Or Master’s degree and 2 years of Operations or Process Development experience
Or Bachelor’s degree and 4 years of Operations or Process Development experience
Or Associate’s degree and 8 years of Operations or Process Development experience
Or High school diploma / GED and 10 years of Operations or Process Development experience
M.S. or PhD in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field
5+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
Familiarity with aseptic processing, drug product manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization
Process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools
Knowledge of bringing new products to market, across various dosage forms and delivery systems
Knowledge of associated GMP/Device documentation and regulatory filings
Experience with conducting statistical evaluations of data to evaluate statistical significance, assess potential correlations, evaluate process capability and/or perform Monte Carlo simulations.
Familiarity with the application of AI-enabled tools to support process characterization, process monitoring, and data-driven decision making in drug product development and manufacturing.
Experience in a matrix team environment, in particular interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
Interpersonal, communication and facilitation skills necessary to represent functional position, and forge consensus among competing client interests while ensuring objectives are met
Ability to learn and act on dynamic information at a rapid pace
Ability to travel domestically and internationally up to 25% of the time.

Benefits

Comp & perks

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
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.

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Hard Skills & Tools

drug product process developmentaseptic processingcGMPstatistical designprocess characterizationprocess scale-uptechnology transferrisk assessmentdata evaluationMonte Carlo simulations

Soft Skills

interpersonal skillscommunication skillsfacilitation skillsconsensus buildingadaptabilityproblem-solving

Certifications

PhD in Chemical EngineeringPhD in Biomedical EngineeringM.S. in Pharmaceutical SciencesM.S. in ChemistryM.S. in BiochemistryM.S. in Biotechnology