Engineer – Physical Test Method Development & Validation (Medical Devices / Combination Products)

3key Consulting, Inc.; Massachusetts; On-site; USD 56,000 - 63,000; Part time

Job summary

3key Consulting, Inc. in Cambridge, MA is seeking an Engineer – GMP Test Methods Development & Validation for a 2+ year contract with potential extensions.

The role focuses on development, validation, and lifecycle management of physical test methods and associated equipment within a regulated biopharmaceutical setting. The ideal candidate will have strong engineering fundamentals, experience with validation (IQ/OQ/PQ), data analysis, and the ability to produce well-documented results.

Qualifications

• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
• Experience in regulated industry and GMPs preferred
• Excellent verbal and written communication skills to communicate project status and risks to leadership
• Willingness to work onsite in Cambridge, MA

Responsibilities

• Develop and support lifecycle management of physical GMP test methods and associated documentation (test method protocols, SOPs, training documents, etc.)
• Execute test method protocols, analyze data
• Maintain projects status and communicate with companyinternal clients

Skills

Strong communication

Project management

Data analysis

Education

Master's or Bachelor's with experience

Tools

CAD

SolidWorks

Job description

Engineer – Physical Test Method Development & Validation (Medical Devices / Combination Products)

• Ca, MA
• Biotech/Pharmaceutical

Job Title: Engineer – Physical Test Method Development & Validation (Medical Devices / Combination Products - (JP16020)

Location: Cambridge, MA. 02138

Employment Type: Contract

Business Unit: Physical Methods Development, Modelling and Emerging Methods

Duration: 2+ year with likely extensions and/or conversion to permanent

Posting Date: 09/23/26

Pay Rate: $41 - $46/hour W2 with benefits

3 Key Consulting is hiring anEngineer – GMP Test Methods Development & Validation fora consulting engagement with our direct client, a leading global biopharmaceutical company.

This position involves support of senior staff in the initiation, design, and delivery of projects, particularly for the Combination Product Operations MS&T - Physical Sciences and Engineering (PSE) organization. Responsibilities include development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods.

The successful candidate employs basic engineering skills and practices to gather user requirements and translate them into technical documentation. Assist with project definition by performing engineering studies and assessment for automated test systems installations. Perform field evaluations of existing systems and provide engineering design recommendations.

The ideal candidate enjoys tackling challenges and excels at organizing information from numerous sources to provide well-constructed deliverables. This individual has a passion for modeling, analytics, and technology. The successful candidate will be given opportunities to apply their expertise to enhance the way data is used to inform and make decisions. This may include, but is not limited to, the following:

• Collaborate with Engineers using the system to edit, develop, and run automated, experimental protocols.
• Knowledge on Equipment and Method validation principles, generation of Lifecycle Documentation such as FAT/SAT, IQ/OQ, equipment characterization protocols, Gauge Repeatability and Reproducibility studies
• Assisting Engineers to successfully develop, transfer and execute processes on the integrated platforms and equipment.
• Developing, enhancing, automating, and managing test data
• Network with manufacturing and quality organizations internal to company
• Ensuring all tasks and responsibilities are performed according to industry-leading scientific standards & accurately documented per SOPs
• Monitoring technological developments in the field & evaluation of new technologies

Why is the Position Open?

Supplement additional workload on team

Top Must Have Skills:

• Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
• Ability to manage multiple, competing priorities simultaneously
• Statistical analysis and knowledge of Gage R&R

Day to Day Responsibilities:

• Develop and support lifecycle management of physical test methods and associated documentation (test method protocols, SOPs, training documents, etc.)
• Execute test method protocols, analyze data
• Maintain projects status and communicate with companyinternal clients

Basic Qualifications:

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

Preferred Qualifications:

• Experience working in a regulated industry, exposure to GMPs
• Excellent verbal and written communication skills to communicate project status and risks associated with integrated timelines to leadership
• Statistical analysis, and knowledge of Gage R&R,
• Knowledge of Optical measurement devices, force testers, BLE testing
• Test method development, CAD design, Solidworks, mechanical modeling
• Manufacturing experience, IQ, OQ, and PQ
• Passion for proactively identifying opportunities through creative data analysis and modeling
• Intellectual curiosity with ability to learn new concepts/frameworks, algorithms, and technology rapidly as needs arise
• Ability to manage multiple, competing priorities simultaneously, experience with MS Project

Red Flags:

• Not local to AMA and cannot commit to onsite work.
• No Bachelors.
• Not a document review role, not interested in candidates with background in QC or QA experience only.
• Not interested in lab work setting.

Interview process:

• 1:1 Initially Phone
• 1:5 Panel Interview (can be in person) if candidates have some project portfolio they wish to share would be great.