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Process Engineer Intern


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Company

Aprecia Pharmaceuticals, LLC

Description

General Purpose of Position:
The Process Engineer Intern will work with subject matter experts and be responsible for developing core technical proficiencies on the equipment, processes, and procedures for application of Aprecias proprietary three-dimensional printing (3DP) technology for Technical Transfer and scale up of Aprecias products to commercial manufacturing at Blue Ash, OH facility.

Primary Duties and Responsibilities (Essential Functions):

Duties/Responsibilities
1 Assist and take part in specific projects in review of late stage Product Development efforts in formulation, process robustness and manufacturing controls, learning and assisting with technology transfer or process validation required to achieve a successful transition
2 Provide support to existing Process Engineers for each stage of development in the pharmaceutical development process as needed and product lifecycle activities
3 Learn and provide support for risk analysis performed in Technical Services and assure appropriate parameters are evaluated. Training on appropriate statistical approaches associated with testing for justification and support of critical process parameters and quality attributes
4 Collect data and assist in database assembly for Aprecia products. Learn statistical methods for evaluation of raw material critical quality attributes (CQA), in-process testing and critical process parameters (CPP) for continuous process improvement and annual report evaluations.
5 Assist in review of technical memos, qualification/validation protocols and reports for cleaning and manufacture of drug product to demonstrate a state of control
6 Execute sampling and testing as needed for Technical Services protocols
7 Assist in reviewing SOPs (standard operating procedures) for production where the introduction of new products or processes are being addressed
8 Manage specific project details as delegated for technical transfer and continuous improvement efforts within Aprecia
9 Communicate effectively with multidisciplinary teams as required and present findings to department heads, project managers, and the wider development teams as required
10 Other duties as assigned.

Reporting to this Position:
No direct reports

Travel:
Position may require 10% travel

Work Shift:
Responsibilities for this role may be covered across multiple shifts

Knowledge, Skills and Abilities:
Good organizational skills with a collaborative approach to problem solving
Excellent written and verbal communication skills
Self-directed and motivated for completion of projects
Data base assembly knowledge preferred
Statistical analysis and management of data experience preferred
Familiarity with MS Office Suite

Education and Experience:
Working towards a B.S. degree in Engineering, Chemistry, Computer Science, Math or a related discipline required
Manufacturing background, project management skillset, and 3rd and 4th year students with previous intern experience preferred

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
No facial hair other than a moustache is allowed for individuals in this position due to respirator fit issues


GENERAL INFORMATION:
The expectation for all employees is to support the companys 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.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Associated topics: bioengineering, biomedical engineer, biophysics, biosynthetic, fermentation, molecular, msat, neuro, neuroscience, pathogenesis
Posted Date
04/23/2021

Listing ID
76540076
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