1 Lead Process Development Engineer Job in Blue, OH
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Lead Process Development Engineer
$104k-122k (estimate)
Full Time | Pharmaceutical
3 Weeks Ago
Aprecia Pharmaceuticals is Hiring a Lead Process Development Engineer Near Blue, OH
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):
Reporting to this Position:No direct reportsTravel:Position may require 0-10% travelWork Shift:This position works daysKnowledge, Skills and Abilities:
| 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 reportsTravel:Position may require 0-10% travelWork Shift:This position works daysKnowledge, 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
- 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
- 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.)
Job Summary
JOB TYPE
Full Time
INDUSTRY
Pharmaceutical
SALARY
$104k-122k (estimate)
POST DATE
04/16/2024
EXPIRATION DATE
06/15/2024
WEBSITE
aprecia.com
HEADQUARTERS
EAST WINDSOR, NJ
SIZE
100 - 200
FOUNDED
2004
TYPE
Private
CEO
PAT ZAFARINO
REVENUE
$5M - $10M
INDUSTRY
Pharmaceutical
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About Aprecia Pharmaceuticals
Aprecia Pharmaceuticals develops, manufactures and commercializes precision drug delivery systems and other related products.
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