Career CategoryEngineering
Job DescriptionEngineer I (Lab Testing & Operations)What you will doLet's do this. Let's change the world. In this vital role you will join a high-performing engineering team at one of the world's most innovative biopharmaceutical companies. This position reports into the Combination Product Systems Engineering group in Cambridge, MA and is responsible for hands-on laboratory work including drug delivery device characterization testing, lab operations, equipment stewardship, and technical documentation supporting medical device and combination product development. The role applies engineering principles in a laboratory environment to generate high-quality data, execute test protocols, maintain compliant lab practices and safety, and build team capability through training and process improvement.
- As part of a team, 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.
- enerate 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
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. Engineer professional we seek is an individual with these qualifications.
Basic Qualifications:- 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
Preferred Qualifications:- >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 you can expect of usAs 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.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comSalary Range88,281.00USD -119,439.00 USD
