Engineer I (Lab Testing & Operations) Job at Amgen (Cambridge)

Job Responsibility

Plan and execute hands-on device and final product characterization testing for biological drug delivery systems and combination products in a controlled laboratory setting
Operate and serve as the team's technical resource for laboratory equipment such as viscometers, densitometers, UV-Vis spectrometers, 3D printers, environmental chambers, tensile testers, manual presses, balances, and standard wet-lab tools
Author, review, and execute test protocols, workbooks, test methods, reports, and other technical documentation in accordance with GDP and GLP expectations
Document experiment design, methods, sample traceability, results, and observations in electronic laboratory notebook systems with a high degree of rigor and accuracy
Perform statistical and engineering data analysis
summarize findings clearly and provide technical recommendations to enable project decisions
Support cross-functional development programs through lab testing, data verification, sample management, and coordination with team members and partner functions
Maintain laboratory readiness through equipment coordination, preventive maintenance support, calibration readiness, workspace organization, and implementation of best practices
Maintain a high standard of safety in day-to-day lab operations by providing safety oversight to all activities, leading by example with lab safety best practices, participating in regular lab safety assessments and walkthroughs with EH&S staff
Lead or support laboratory continuous-improvement efforts, including workflow optimization, 5S sustainment, safety initiatives, and storage/process improvements
Train new and existing staff on laboratory procedures, equipment use, documentation standards, and safe/compliant laboratory practices
Contribute to technical problem solving, root-cause analysis, and practical implementation of improved methods, fixtures, or workflows
Generate high-quality experimental data to support product characterization, feasibility assessments, and development milestones
Partner with device and systems engineers, test teams, drug product teams, scientists, and other cross-functional stakeholders to align test execution with project needs and timelines
Provide day-to-day laboratory operational support as a team lab captain / area steward, including inspections, readiness activities, and escalation of equipment or facility needs
Support digital transformation workflows by organizing test data, maintaining traceability, and creating dashboards or data summaries that inform project decisions and lab operations
Act as a subject matter resource for selected laboratory methods and equipment and help transfer knowledge across the team
Ensure documentation, data review, and reporting are complete, clear, and inspection ready
Promote a culture of safety, quality, accountability, and collaboration in all laboratory activities

Requirements

Master's degree
OR Bachelor's degree and 2 years of Engineer experience
OR Associate's degree and 6 years of Engineer experience
OR High school diploma / GED and 8 years Engineer experience

Nice to have

>5 years hands-on laboratory experience supporting scientific, engineering, or product testing activities
Experience authoring or executing technical documentation such as protocols, reports, work instructions, or laboratory records
Strong written and verbal communication skills
Demonstrated attention to detail, organization, and ability to manage multiple priorities in a fast-paced environment
Demonstrated capability to train others, improve workflows, and support continuous improvement initiatives
Demonstrated ability to work independently and collaboratively in a team environment
Experience in pharmaceutical, medical device, or combination product development environments
Working knowledge of Good Documentation Practices (GDP), Good Laboratory Practices (GLP), and laboratory safety expectations
Experience with characterization or support equipment such as viscometers, densitometers, UV-Vis instruments, tensile testers, environmental chambers, or 3D printers
Experience with data visualization, dashboarding, or business intelligence tools such as Tableau, Power BI, Spotfire, JMP, or similar platforms
Experience with Electronic Lab Notebooks such as Dassault 3DS Biovia or similar
Knowledge of statistics and data analysis methods and tools such as JMP or Minitab
Experience with CAD, SolidWorks, or other engineering tools
Strong problem-solving skills, sound technical judgment, and a collaborative, service-oriented mindset

What we offer

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
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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Engineer I (Lab Testing & Operations)

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