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Lead Process Development Engineer - Blue Ash, United States - Aprecia Pharmaceuticals
Description
General Purpose of Position:
Fill a key role on a team of engineers and scientists tasked with the innovation and development of proprietary and non-proprietary processes and process technologies to be used in the development and manufacture of commercially viable pharmaceutical products based on additive manufacturing platforms.
Responsible for supporting the engineering and development of innovative technologies, equipment, processes, and material sets in collaboration with engineering teammates such that pharmaceutical product developers are equipped with a broad and reproducible "toolset" from which to rapidly and confidently develop commercially viable products.
Provide process expertise for the design, development, installation, and validation of Aprecia's proprietary 3DP (three-dimensional printing) technology platforms.Responsible for expanding and supporting the technology platform(s) used in Aprecia's product development programs, including development of new processes and intellectual property.
Supports general process needs including factory, site, and/or product acceptance testing of instruments, DOE or general test protocol execution, and other aspects of the development of new (or improvements to existing) pharmaceutical manufacturing equipment intended for commercial production or product development.
Generate and execute various engineering and validation documents associated with Aprecia's manufacturing equipment, ensuring that our pharmaceutical products are manufactured in a manner that accounts for efficiency, safety, quality, and efficacy.
Primary Duties and Responsibilities (Essential Functions):
Duties/Responsibilities
1
Become an operational SME (subject matter expert) on Aprecia's next generation and legacy 3DP manufacturing equipment
2
Coordinate and lead activities regarding the development of automated equipment and processes including developing operational and in process / real time testing concepts and supporting documentation, definition of specifications, risk assessments, design reviews, root cause analyses, and test plan generation and execution in partnership with Design Engineering colleagues
3
Work directly with Product Development, Technical Services, and Manufacturing colleagues to ensure new and existing processes and process technologies meet expectations for performance, flexibility, ruggedness, reproducibility, and cost efficiency
4
Operate laboratory equipment in pursuit of the development of new printing fluids, product material characterization, alternative printing/process technologies, process analytical technologies (PAT), or other engineering development focused activities
5
Collaborate with, and at times manage, technology and integration vendors to ensure projects meet specifications and are delivered on time
6
Oversee collection and statistical evaluation of process data to support / define capabilities of new equipment, in-process testing and determining critical process parameters (CPP) for continuous process improvement
7
Author and review technical memos, qualification/validation protocols and reports for cleaning and manufacture of drug product to demonstrate a state of control
8
Execute sampling and testing as needed based on protocols or test plans to support activities including validation
9
Prepare or review appropriate documentation including change control documentation, URS (user requirement specifications), scope of work documents, and operation / maintenance manuals as required for new or modifications to qualified equipment
10
Project management as delegated for technical transfer and continuous improvement efforts within Aprecia
Reporting to this Position
:
No direct reports
Travel
:
Position may require 0-10% travel
Work Shift
:
This position works days
Knowledge, Skills and Abilities
:
Working knowledge of pharmaceutical industry and cGMPs preferred
Working knowledge of additive manufacturing processes preferred
Strong written, verbal, and interpersonal skills
Statistical analysis, data management, data visualization and presentation skills
Ability to work in a hands-on collaborative fashion with many different disciplines both inside and outside of the company
Experience with structured problem-solving tools and leading multi-disciplinary teams in root-cause-analyses
Binder-Jet/Inkjet printing technology operational/troubleshooting experience desired
Powder bed additive manufacturing operational/troubleshooting experience desired
Project management and/or vendor management experience desired
Ability to manage multiple projects simultaneously
Ability to learn and adapt to demands in a fast paced, advanced technology development work environment
Mechanical/electrical assembly, wiring, and troubleshooting capability a bonus
Machining/fabrication/welding skills a bonus
PLC/Controls/Programming skills a bonus
Education and Experience
:
B.S. degree in Engineering, Chemistry, Math or a related discipline required
M.S. degree in Engineering, Chemistry, Math or a related discipline desired
Minimum 5-10 years of experience in the pharmaceutical industry or additive manufacturing industry with experience in developing novel equipment, processes, technology and/or modifying existing process trains and materials to achieve novel endpoints
Experience in technology development and maturation from early proof-of-concept to production scale implementation required
Hands-on experience operating/troubleshooting/testing/improving manufacturing equipment required
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 testing equipment, 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.)
GENERAL INFORMATION
:
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.We are an equal employment opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.
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