Senior Engineer

Amgen

Senior Engineer handling late-stage drug product formulation and fill/finish process development at Amgen. Leading technical projects and collaborating with multi-functional teams for commercialization.

Posted 5/15/2026full-timeThousand Oaks • California • 🇺🇸 United StatesSenior💰 $115,495 - $156,257 per yearWebsite

About the role

Key responsibilities & impact

Join Amgen’s Mission of Serving Patients
Provide technical and project leadership while integrating information generated by multi-functional teams to ensure success through the commercialization process.
Stay ahead of the latest developments/trends in the industry and scientific community to foster innovation and to meet future business needs.
Provide support for Amgen’s biologics drug product and process design, commercialization and lifecycle management.
Collaborate successfully with colleagues within DPT and cross-functionally
Develop and proceduralize lean study designs for process characterization
Improve operational efficiency via alignment of work across teams.
Conduct laboratory studies related to formulation, aseptic processing, visual inspection and fill/finish process development in support of product commercialization and life cycle management
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
Conduct risk assessment for inspection operations and propose / implement appropriate CAPA.
Coordinates and organizes resources needed to complete tasks.

Requirements

What you’ll need

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
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.

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.

ATS Keywords

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Hard Skills & Tools

aseptic processingfillingvisual inspectionprocess characterizationstatistical process controldata analyticsprocess monitoring toolsdigital process control systemsmachine learningadditive manufacturing

Soft Skills

project managementleadershipcollaborationcommunicationorganizational skillsrisk assessmentproblem-solvinginnovationoperational efficiencycross-functional teamwork