What are the responsibilities and job description for the Engineer position at Aditi Consulting?
Summary:
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for automation related projects in the Process Development Organization, within the Combination Product Operations. The candidate will be a part of the Commercial Platform Methods and Automation team where the responsibilities include 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.
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.
Responsibilities:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for automation related projects in the Process Development Organization, within the Combination Product Operations. The candidate will be a part of the Commercial Platform Methods and Automation team where the responsibilities include 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.
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.
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.
- Troubleshooting of various lab instruments and automation systems, which will require learning the specific software controlling the instruments and integrated systems from vendor manuals, and site documents.
- 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
- 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.
- 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.
- 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 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
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
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