Overview
On Site
Full Time
Skills
Conflict Resolution
Problem Solving
Reporting
Preventive Maintenance
Project Management
Performance Management
Biomedical Engineering
Pharmaceutics
Biomedicine
Science
GMP
Lifecycle Management
Integration Testing
Technical Writing
Automated Testing
Engineering Design
Organizational Skills
Analytics
Collaboration
Editing
Documentation
Network
Evaluation
Communication
Leadership
Statistics
Testing
Test Methods
SolidWorks
Mechanical Engineering
Manufacturing
IQ
OQ
PQ
Data Analysis
Modeling
Algorithms
Management
Job Details
Location: Thousand Oaks Local Candidates Only** Potential for Hybrid
Duration: 18 months with possible 18-month extension based on performance
The ideal candidate is a junior to mid-level Mechanical or Biomedical Engineer (Bachelor's degree, 1-3 years of experience, Master's acceptable) with hands-on pharmaceutical or biomedical industry experience. They must demonstrate proficiency in statistical analysis, Gauge R&R, and optical measurement devices while having basic working knowledge of CAD/SolidWorks for simple designs. Strong familiarity with GMP documentation practices and ability to write technical documents is critical. The best fit will be local to Thousand Oaks or open to relocation, motivated to work in a hybrid on-site model, and able to show problem-solving ability and a willingness to learn.
What location will this position be tied to? Client Thousand Oaks (ATO)
Will there be any opportunity for remote work? This is a Hybrid position. 2 days on site and 3 days work from Home. This might vary depending on projects and business needs.
What are the exact shift hours/schedule the contractor will be working/reporting? 8AM-5PM PT- Client Core Business hours
What type of qualities/characteristics are you looking for in candidates to work best with your team? Someone who is motivated to work both individually and in a team.
When reviewing resumes, what stands out to you when looking for the right applicants? Previous projects/job experience.
What is your minimum education and years of work experience you think it most suitable for this role? Minimum education in BS in Mechanical/Biomedical Engineering with 1-3 years of experience preferably in Pharmaceutical/Biomedical industry.
Job Details: 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 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
Preferred Skills
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, Solid works, mechanical modeling
Manufacturing experience, IQ, OQ, and PQ
Preferred Traits:
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, Smartsheet
Duration: 18 months with possible 18-month extension based on performance
The ideal candidate is a junior to mid-level Mechanical or Biomedical Engineer (Bachelor's degree, 1-3 years of experience, Master's acceptable) with hands-on pharmaceutical or biomedical industry experience. They must demonstrate proficiency in statistical analysis, Gauge R&R, and optical measurement devices while having basic working knowledge of CAD/SolidWorks for simple designs. Strong familiarity with GMP documentation practices and ability to write technical documents is critical. The best fit will be local to Thousand Oaks or open to relocation, motivated to work in a hybrid on-site model, and able to show problem-solving ability and a willingness to learn.
What location will this position be tied to? Client Thousand Oaks (ATO)
Will there be any opportunity for remote work? This is a Hybrid position. 2 days on site and 3 days work from Home. This might vary depending on projects and business needs.
What are the exact shift hours/schedule the contractor will be working/reporting? 8AM-5PM PT- Client Core Business hours
What type of qualities/characteristics are you looking for in candidates to work best with your team? Someone who is motivated to work both individually and in a team.
When reviewing resumes, what stands out to you when looking for the right applicants? Previous projects/job experience.
What is your minimum education and years of work experience you think it most suitable for this role? Minimum education in BS in Mechanical/Biomedical Engineering with 1-3 years of experience preferably in Pharmaceutical/Biomedical industry.
Job Details: 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 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
Preferred Skills
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, Solid works, mechanical modeling
Manufacturing experience, IQ, OQ, and PQ
Preferred Traits:
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, Smartsheet
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.