Engineer Top 3 Must Have Skill Sets: - 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
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. 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.
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 to our 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.
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, SolidWorks, mechanical modeling.
- Manufacturing experience, IQ, OQ, and PQ.
Basic Qualifications: 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 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.
Pay range is $31 - $36 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.