Engineer - Drug Substance Technology & Engineering

Amgen•Thousand Oaks, CA

9h•Onsite

About The Position

Amgen is seeking an Engineer to join its Drug Substance Technology & Engineering team at the Thousand Oaks, California site. This onsite role provides downstream purification process engineering support for clinical and commercial biologics drug substance products across the network. The Engineer supports technology transfer, process validation, and manufacturing for human therapeutic products from clinical development through commercial production, applying engineering principles to implement processes in a cGMP environment. The role translates developmental processes into commercial manufacturing through scientific expertise and engineering innovation. The Engineer works with engineers and scientists and collaborates with Manufacturing, Quality, Regulatory, Research, Maintenance, Utilities, Facilities, and Validation teams. The position operates under general supervision, addressing technical problems of moderate scope and complexity and seeking assistance with unusual problems. Support for nonstandard shift schedules and extended hours may be required as business needs dictate.

Requirements

Master’s degree; or bachelor’s degree and 2 years of Process Development experience; or associate degree and 6 years of Process Development experience; or high school diploma/GED and 8 years of Process Development experience.
Ability to apply engineering principles and standard engineering techniques and procedures under general supervision.
Ability to investigate a limited number of variables and address technical problems of moderate scope and complexity.
Ability to support nonstandard shift schedules and extended hours when business needs require.
Strong scientific, engineering, and laboratory analysis and troubleshooting capabilities, including sophisticated problem-solving abilities.
Ability to develop and follow detailed protocols.
Ability to work independently, multitask, and work in teams.
Excellent written and verbal communication skills, including technical writing and presentations.

Nice To Haves

Master’s degree in Chemical Engineering, Biochemical Engineering, or a related subject area.
3 or more years of Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles, and cGMP biologics manufacturing.
Downstream process knowledge and hands-on purification pilot, clinical, or commercial experience in biological drug substance manufacturing.
Experience working in or supporting a commercial cGMP manufacturing facility.
Firm understanding of purification processes and related equipment; scale-up from bench to commercial scale; chromatography; viral inactivation; viral filtration; ultrafiltration and diafiltration; and the impact of process deviations on yield and quality attributes.
Knowledge of aseptic processing and techniques, harvest and clarification processes used in mammalian cell culture, and/or purification processes and associated equipment, including chromatography, ultrafiltration, normal flow filtration, virus inactivation, and virus filtration operations.
Process Development experience supporting large-scale cGMP manufacturing.

Responsibilities

Transfer purification drug substance processes and process improvements from laboratories to manufacturing facilities and between manufacturing sites.
Provide solutions to technical problems of moderate scope and complexity.
Evaluate, select, and apply standard engineering techniques and procedures under general supervision, seeking assistance for unusual problems.
Support process validation for late-stage commercial processes.
Provide on-the-floor technical support for process scale-up, technology transfer, and clinical and commercial manufacturing operations.
Perform routine and nonroutine process monitoring and troubleshooting.
Support nonstandard shift schedules and extended hours as business needs require.
Trend process data and perform statistical analyses.
Provide technical input for process-related deviations, nonconformances, CAPAs, and change controls.
Identify and support operational excellence and continuous improvement opportunities related to processes, including efficiency improvements across business process workstreams.
Represent Process Development and collaborate with Manufacturing, Quality, Regulatory, Research, Maintenance, Utilities, Facilities, and Validation teams to develop requirements and recommendations for process or system modifications.
Communicate and collaborate with technical and management staff across Manufacturing, Process Development, and Quality.
Complete assignments with clear objectives that require investigating a limited number of variables.
Serve as a technical expert for equipment and systems troubleshooting and participate in daily operations as needed to meet schedules or resolve complex problems.
Apply engineering principles and statistical methods, including design of experiments, to resolve processing issues and evaluate process improvement opportunities.