- GMP process equipment design, testing, characterization and validation
- ***Will work on packaging and medical device equipment
- See description and skill sets
- Key responsibilities will include supporting the Technical Transfer of the company's product portfolio to AOH. 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 company's commercial site network with all stakeholders and deliver on technical improvements.
- Act as a subject matter expert for FDP GMP operations at AOH, 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.
- Responsible for supporting the delivery of productivity, throughput and general capacity improvements across the AOH manufacturing lines by analyzing, designing, and implementing manufacturing and business process improvements.
- 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
- Doctorate degree and 2 years of experience
- Master degree and 6 years of experience
- Bachelor degree and 8 years of experience
- Associate degree and 10 years of experience
- High school diploma / GED and 12 years of experience
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Engineer Principal - New Albany, United States - Crystal Equation
Description
Engineer Principal
Top 3 Must Have Skill Sets:
The Engineer position reports into the Senior Manager Engineering under Process Development at the Ohio (AOH) facility. This position requires the application of diverse and advanced engineering and scientific principles in support of Final Drug Product (FDP) commercial GMP operations at AOH.
FUNCTIONS
The Engineer will support the development and implementation of technical solutions for a variety of engineering initiatives supporting the FDP commercial GMP operations at AOH. 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
The Engineer is expected to build a network of FDP expertise within AOH and across other company 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 at AOH.
Competencies/Skills:
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.
