Senior Validation Engineer – GMP Laboratory Equipment Qualification & Inspection Systems - (JP16020)

3key Consulting, Inc.; Kansas; Presencial; USD 56.000 - 63.000; Jornada completa

Descripción de la vacante

3key Consulting is hiring a Senior Validation Engineer for GMP Laboratory Equipment Qualification & Inspection Systems in Cambridge, MA. The role supports the Combination Product Operations MS&T - Physical Sciences and Engineering, focusing on validation methods, equipment qualification, and lifecycle documentation.

The ideal candidate has a 3+ years background in regulated environments, GMP exposure, experience with test method development, CAD/SolidWorks, and data analytics.

Formación

• Experience in regulated industry; GMP exposure preferred.
• Hands-on lab experience and ability to generate technical documentation.
• Experience with test method development and data analysis.

Responsabilidades

• Develop and support lifecycle management of physical test methods and related documentation.
• Execute test method protocols and analyze data.
• Maintain project status and communicate with internal clients at Amgen.

Conocimientos

Verbal communication

Project management

Statistics

Gage R&R

Educación

Bachelor's degree in engineering or science

Master's degree (preferred)

Herramientas

CAD design

SolidWorks

Descripción del empleo

Senior Validation Engineer – GMP Laboratory Equipment Qualification & Inspection Systems - (JP16020)

• Ca, MA
• Biotech/Pharmaceutical

Job Title: Senior Validation Engineer – GMP Laboratory Equipment Qualification & Inspection Systems - (JP16020)

Location: Cambridge, MA. 02138

Employment Type: Contract

Business Unit: Physical Methods Development, Modelling and Emerging Methods

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

Posting Date: 09/23/26

Pay Rate: $41 - $46/hour W2

Notes: Only qualified candidates need apply.

3 Key Consulting is hiring a Senior Validation Engineer – GMP Laboratory Equipment Qualification & Inspection for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:

Our ideal candidate will have 3 years of experience in field desired with bachelors degree. Experience working in a regulated industry, exposure to GMPs, Medical Device experience is highly desired. Mathematical background fundamentals of statistics. Useful to have exposure to test method development, CAD design, Solidworks, mechanical modeling. Nice to have programming R and python experience. hands on technical experience useful, comfortable working within a lab.

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 Amgen
• 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 Amgen internal 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 needed
• 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.