Crystal Equation
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Engineer Principal
Top 3 Must Have Skill Sets:
Summary:
The Engineer position reports into the Senior Manager Engineering under Process Development at the Ohio facility. This position requires the application of diverse and advanced engineering and scientific principles in support of Final Drug Product (FDP) commercial GMP operations.
The position is expected to travel for approximately 25%.
Functions:
The Engineer will support the development and implementation of technical solutions for a variety of engineering initiatives supporting the FDP commercial GMP operations. The position is a key role in the Process Development group and the candidate must manage and/or apply extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, validation, maintenance and alteration of systems, facilities and/or processes. This position will also be required to apply advance and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process characterization, optimization, scale up or manufacturing support projects.
Outputs:
Project Management
Technical Support
Operational Excellence
Relationships
Education:
OR
OR
OR
Skills:
Pay range is $43 - $48 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.
Engineer Principal
4150 Ganton Parkway New Albany, OH 43031 US
Posted: 03/06/2024
2024-03-06
2024-05-04
Job Number: 38782
Job Description
Engineer Principal
Top 3 Must Have Skill Sets:
- GMP process equipment design, testing, characterization and validation
- ***Will work on packaging and medical device equipment***
Summary:
The Engineer position reports into the Senior Manager Engineering under Process Development at the Ohio facility. This position requires the application of diverse and advanced engineering and scientific principles in support of Final Drug Product (FDP) commercial GMP operations.
The position is expected to travel for approximately 25%.
Functions:
The Engineer will support the development and implementation of technical solutions for a variety of engineering initiatives supporting the FDP commercial GMP operations. The position is a key role in the Process Development group and the candidate must manage and/or apply extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, validation, maintenance and alteration of systems, facilities and/or processes. This position will also be required to apply advance and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process characterization, optimization, scale up or manufacturing support projects.
Outputs:
Project Management
- Key responsibilities will include supporting the Technical Transfer of the Amgen product portfolio to our new facility. Additional responsibilities will include the provision of technical operations support for the continuous improvement of packaging lines capacity and performance, and advisory of technical improvement projects. The Engineer must ensure effective communication throughout the Amgen commercial site network with all stakeholders and deliver on technical improvements.
Technical Support
- Act as a subject matter expert for FDP GMP operations, and primarily as technical support for new process equipment and technology. This will include GMP process equipment design, testing, characterization and validation. The Engineer will author such documents as well as be responsible for the execution of said protocols. The Engineer is expected to use technical process knowledge and identify the required expertise to resolve process challenges as needed.
Operational Excellence
- Responsible for supporting the delivery of productivity, throughput and general capacity improvements across the manufacturing lines by analyzing, designing, and implementing manufacturing and business process improvements.
Relationships
- The Engineer is expected to build a network of FDP expertise within our new facility and across other Amgen commercial operations for product assembly, label and packaging. The position is expected to leverage this network in support of technical expertise for equipment design, testing, characterization and validation.
Education:
- Doctorate degree and 2 years of experience
OR
- Master degree and 6 years of experience
OR
- Bachelor degree and 8 years of experience
OR
- Associate degree and 10 years of experience
- High school diploma / GED and 12 years of experience
Skills:
- Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.
- Proven track record of contributing to cross-functional projects.
- Strong team work, excellent interpersonal and communication skills.
- Experience with devices/combination products and the associated manufacturing process.
- Experience of working with equipment suppliers.
- Ability to work in a highly regulated and ever changing industry.
- Ability to learn and rapidly adapt to new requirements in a fast moving environment.
- An Operational Excellence approach to work product – driving rapid results.
- A passion to deliver an excellent work product and develop others with an infective positive attitude!
Pay range is $43 - $48 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.
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