Senior Combination Product Test Engineer – Drug Delivery Systems & Product Characterization (JP15956)

3key Consulting, Inc.; Cambridge (MA); Presencial; USD 130.872.000 - 146.026.000; Jornada completa

Descripción de la vacante

3key Consulting, Inc. in Cambridge, MA seeks a Senior Combination Product Test Engineer for drug delivery systems and combination products.

This 1+ year contract role is on-site in Cambridge, with responsibilities spanning planning, executing tests, data analysis, and documentation in a GLP/GDP environment. The ideal candidate has a Bachelor's in engineering or science and 4–5 years of lab experience, with strong hands-on skills and effective communication.

Formación

• Bachelor's degree in engineering or a scientific discipline.
• 4–5 years of relevant professional experience performing laboratory testing, product characterization, or experimental engineering work.
• Demonstrated experience planning or executing tests, analyzing data, and documenting technical work.
• Strong hands-on skills and interest in working daily in a laboratory environment.
• Effective written and verbal communication skills, including the ability to prepare protocols, reports, technical assessments, or presentations.
• High attention to detail and a methodical approach to experimental work, data integrity, and material traceability.
• Ability to manage multiple priorities and work independently while coordinating with a broader technical team.

Responsabilidades

• Plan and perform hands-on engineering tests to characterize drug delivery systems and combination products per GLP/GDP.
• Operate and troubleshoot lab equipment (3D printers, testers, environmental chambers, balances).
• Develop or refine test methods and workflows; identify improvements.
• Prepare and execute test protocols; document deviations; write technical reports.
• Maintain complete ELN records of experiments and data.
• Analyze data; draw conclusions; communicate results to staff.
• Investigate failures; perform root-cause analysis; recommend next steps.
• Coordinate maintenance and calibration; ensure equipment readiness.
• Coordinate testing timelines across projects and communicate risks.
• Share knowledge and promote best lab practices.

Conocimientos

Hands-on lab testing

Data analysis

GLP/GDP documentation

Technical communication

Lab equipment operation

Educación

Bachelor's degree in engineering or science

Herramientas

3D printing

Tensile testing

Viscosity testing

Environmental chambers

Arbor presses

Analytical balances

Descripción del empleo

• Cambridge, MA
• Biotech/Pharmaceutical

Senior Combination Product Test Engineer - Drug Delivery Systems & Product Characterization (JP15956)

Location: Cambridge, MA. 02138

Employment Type: Contract

Business Unit: Combination Product Operations Transformation

Duration: 1+ year (with likely extensions and/or conversion to permanent)

Posting Date: 09/8/26

Pay Rate: $46 - $51/hour W2

Notes: Only qualified candidates need apply.

Job Description

This lab-based contract position reports to the Systems Engineering group in Cambridge, Massachusetts. The role independently plans and performs laboratory testing to characterize combination products and drug delivery systems, analyzes results, and communicates findings and recommendations to support engineering decisions. The successful candidate will also help maintain a well-organized, compliant laboratory, including equipment preventive maintenance and calibration.

The role applies engineering or scientific principles to practical testing challenges and coordinates effectively across functions. It requires sound judgment, careful documentation, and the ability to manage multiple work activities with appropriate guidance from senior technical staff. This position is 100% on-site.

Why is the Position Open?

Supplement additional workload on team

Top Must Have Skills

Hands-on laboratory testing and experimental execution

• Experience independently planning and running product characterization or engineering tests, operating lab equipment, troubleshooting issues, and working carefully with samples and materials. Experience with combination products, medical devices, or pharmaceuticals would be especially relevant.
• Data analysis and engineering problem-solving
• Ability to analyze test results, apply basic statistics, investigate unexpected outcomes, and turn findings into clear conclusions and practical recommendations.
• Regulated documentation and technical communication
• Working knowledge of GLP and GDP, with the ability to maintain traceable ELN records and independently author or execute protocols and technical reports. The person should also be able to explain findings clearly to cross-functional partners.

Day to Day Responsibilities

• Independently plan and perform hands-on engineering tests and experiments to characterize drug delivery systems and combination products in a controlled laboratory setting, following applicable Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
• Operate and troubleshoot laboratory equipment such as 3D printers, tensile testers, viscosity testers, environmental chambers, arbor presses, and basic wet-lab equipment, including transfer pipettes, micropipettes, and balances.
• Develop or refine test methods and workflows, identify practical improvements, and recommend changes that improve testing quality, efficiency, or product performance.
• Prepare and execute test protocols, document deviations or unexpected results, and author technical reports that clearly summarize methods, results, limitations, and conclusions.
• Maintain complete and traceable records of experimental design, materials, methods, techniques, results, and samples in an Electronic Lab Notebook (ELN).
• Analyze test data using appropriate statistical methods, draw evidence-based conclusions, and communicate findings and recommendations to technical staff and cross-functional partners.
• Investigate test failures, unexpected results, and equipment or process issues; apply structured problem-solving and root-cause analysis to recommend next steps.
• Support laboratory readiness by coordinating preventive maintenance and calibration activities, maintaining equipment records, and promoting safe, organized work practices.
• Coordinate testing activities and timelines across concurrent projects, proactively communicate risks or changes, and deliver work with limited day-to-day direction.
• Share technical knowledge and effective laboratory practices with colleagues and contribute to a collaborative, adaptable team environment.

Basic Qualifications

• Bachelor’s degree in engineering or a scientific discipline.
• At least 4-5 years of relevant professional experience performing laboratory testing, product characterization, or experimental engineering work.
• Demonstrated experience planning or executing tests, analyzing data, and documenting technical work.
• Strong hands-on skills and interest in working daily in a laboratory environment.
• Effective written and verbal communication skills, including the ability to prepare protocols, reports, technical assessments, or presentations.
• High attention to detail and a methodical approach to experimental work, data integrity, and material traceability.
• Ability to manage multiple priorities and work independently while coordinating with a broader technical team.

Preferred Qualifications

• Experience in the pharmaceutical, medical device, combination product, or other regulated industry.
• Experience with wet-lab methods and product or device testing.
• Working knowledge of GLP and GDP.
• Experience with statistical analysis tools such as JMP or Minitab.
• Experience with 3D modeling or CAD.
• Basic programming experience, such as C or Python.
• Strong problem-solving, troubleshooting, and root-cause analysis skills.
• Organized, collaborative, and adaptable, with the ability to learn new methods and respond to changing project priorities.

Red Flags

• Does not meet the minimum qualifications of at least 4-5 years of relevant experience.
• Has limited recent, hands-on laboratory testing or product-characterization experience; background is primarily theoretical, design-only, or administrative.
• Cannot describe how they maintain accurate, traceable records or follow GLP/GDP practices when documenting test work.
• Has limited experience analyzing test data, troubleshooting unexpected results, or communicating evidence-based conclusions.
• Examples suggest they need close day-to-day direction to plan and complete assigned testing work.
• Cannot meet the role’s 100% on-site requirement in Cambridge, Massachusetts.

Interview process

Phone screen with manager, then 2-3 interviews with peers. Video-call.