3 Key Consulting, Inc. · 4 months ago
Engineer – Mechanical Design & Test Method Development (JP14414)
Thousand Oaks, CA
Full-time
Hybrid
Entry, Mid Level
$36/hr - $41/hr
1+ years exp3 Key Consulting, Inc. is hiring an Engineer for a consulting engagement with a leading global biopharmaceutical company. The role involves supporting senior staff in the initiation, design, and delivery of projects, particularly in the Combination Product Operations MS&T - Physical Sciences and Engineering organization, with a focus on mechanical design and test method development.
AdviceCloud ComputingInformation TechnologyStaffing Agency
Responsibilities
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 client
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
Support FTE Engineers developing Methods and performing testing
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
Create and revise documentations
Development and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development and validation of test methods
Qualification
Required
Bachelor's degree in Mechanical or Biomedical Engineering or equivalent experience
1–3 years of experience in the pharmaceutical or biomedical industry
Proficiency in statistical analysis and Gauge R&R
Basic working knowledge of CAD/SolidWorks for simple designs
Strong familiarity with GMP documentation practices
Ability to write technical documents
Motivated to work in a hybrid on-site model
Problem-solving ability and willingness to learn
Preferred
Experience working in a regulated industry, exposure to GMPs
Excellent verbal and written communication skills to communicate project status and risks
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
Ability to manage multiple, competing priorities simultaneously
Experience with MS Project, Smartsheet
Company
3 Key Consulting, Inc.
3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.
51-200 employees
H1B Sponsorship
3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)
Funding
Current Stage
Growth StageLeadership Team
Ahmad Hussein
CEO, Executive Talent Acquisition, Business Development Leader
Recent News
2025-09-29
Company data provided by crunchbase