The Process Engineer will be responsible for designing and implementing processes and workflows to maximize efficiency and maintain quality. Implementation will include utilization of existing equipment as well as scoping and specifying new technology to handle the increased scales of manufacturing. Technologies in include filling equipment as well as automated plate production. Implementation will include working with quality to validate the equipment and performance. The role will be responsible for cost analysis and optimization to ensure efficient operations.
Essential Job Functions:
Design and implement the necessary unit operations, equipment and raw material specifications to produce product efficiently while meeting the process’ quality specifications. Examples of unit operations include automated liquid filling machines, 96-well plate filling, drying and sealing, lateral flow test strips, microfluidic device handling, mixing, etc.
Knowledgeable in requirements and regulations of ISO 13485 or similar GMP operations and local codes for implementing equipment and processes.
Manage projects to a successful conclusion while meeting the customer’s Project Milestones and Delivery Request Date.
Establish initial project plans with internal stakeholders and support the assigned project manager in the implementation of the project.
Develop best practices, routines and innovative solutions to improve production rates and quality of output
Constructs or reviews project proposal or plan to determine time frame, funding needs, facility requirements, regulatory requirements, developing standard operating procedures, material and staffing requirements
Bachelor's Degree in mechanical or chemical engineering or equivalent experience
4 - 8 years of experience in Process engineering or relevant experience. Preferred experience in the diagnostics, medical device, biotechnology or pharmaceutical industries.
Mixing operations, Automated filling machines, laboratory automation for filling and sealing PCR plates, injection molding of microfluidics devices a plus
Process Control, calibration, , implementation and operation of automation in an ISO 13485 GMP environment
Autocad (or solid works), Microsoft Office, ISO 13485 or other cGMP knowledge, PMP a plus
Competencies Required for this Position:
Demonstrated Scientific “problem solving” skills, translated into consultative selling process where the “win” is for both the client and the company
Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance success of project and maintain strong relationships within all parts of company
Positive internal and external relationship management skills
Strong communication and presentation skills
Proven ability to thrive in a start-up /change oriented environment
Self-starter, driven to perform and self-directed
Able to organize and prioritize a diverse set of responsibilities to ensure that focus on growth and success of company is achieved
Proven coaching, mentoring, team-building and leadership skills