General Purpose of Position:
Development of equipment, processes and procedures for application of Aprecia's proprietary three-dimensional printing technology from product development through the scale up and manufacturing of Aprecia's products. Provide direct support for client driven product development, regulatory submission and technical transfer to Operations in Blue Ash.
Primary Duties and Responsibilities (Essential Functions):
1 Develop core technical expertise on one or more aspects of Aprecia's core manufacturing processes such as printing fluid deposition, powder handling and deposition, drying, harvesting, blister packaging, etc
2 Apply improvements or additions to Aprecia's proprietary three-dimensional printing technology to ensure improved control and throughput. This will require active investigation in to new processes and technologies with proof of principle prototyping when appropriate.
3 Provide engineering support to Product Development teams as assigned including but not limited to operation of development equipment, product design, technical report writing, and regulatory submission.
4 Participate in preparations for technology transfer of new products, processes and equipment to Technical Services and Manufacturing. This would likely involve periodic travel to Blue Ash during the transfer portion of the project.
5 Participate with technology and integration vendors for equipment-related projects
6 Generate equipment or process design, SOP, or validation documents based on subject matter expertise
7 Support Production and Operations Engineering departments regarding operation, support and validation of manufacturing equipment
8 Comply with internal procedures and cGMPs
Reporting to this Position:
No direct reports
Position may require 10-25% travel
This position typically works days, but responsibilities for this role may be covered across multiple shifts
Knowledge, Skills and Abilities:
Solid knowledge of material characterization and process experience with pharmaceutical powder based solid oral formulations
Practical understanding of statistical control and software for data management and evaluation
Experience working with technical projects that span multi-functional teams
Excellent problem solving skills using team-based approach and known techniques for root cause analysis
Good writing skills for clear communication and accurate reporting
Good organizational skills with a collaborative approach to problem-solving
Education and Experience:
B.S. degree (or higher) in a technology field or related discipline (applicable to equipment automation or pharmaceutical sciences) required
1-2 years of experience in pharmaceutical development or manufacturing, and/or innovative technology platforms such as three dimensional printing
Experience with pharmaceutical active drug products (APIs) and excipients used in tableting is a plus.
Physical Demands and Work Environment:
Good eyesight to read, interpret, and create technical materials
Good manual dexterity to operate computer and other general office equipment
Sitting at a desk or standing for extended periods of time
Occasional lifting of boxes (up to 25 pounds) containing engineering materials, manuals, tools, etc.
Exposure to odd body positions (i.e. twisted torso, bent over position, etc.) for brief periods of time while completing validation work in the laboratories or manufacturing areas taking samples, documenting batch information, etc.
Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (e.g. respirators, over-gowning, gloves, safety shoes, safety glasses, etc.) Uniforms, gloves, hairnet, and moustache cover and barrier outerwear is required within the manufacturing area
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies. The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company.