Principal Engineer

3 weeks ago

New Albany, United States Infotree Global Solutions Full time

Description:


ONSITE USOH


The Engineer position reports into the Senior Manager Engineering under Process Development at the Client Ohio (OH) 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 Client product portfolio. 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 Client 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 and across other Client 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.


Competencies/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


Basic Qualifications

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 OR High school diploma / GED and 12 years of experience


Top 3 Must Have Skill Sets:

GMP process equipment design, testing, characterization, and validation

***Will work on packaging and medical device equipment


Day to Day Responsibilities:

  • 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.

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