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Job (this posting is now closed/inactive)


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General Information

(3596587)

Job title: Process Engineer II/III, MDI Manufacturing
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Job location: Durham, NC  22703 United States
Requisition code:
Date posted: 03/15/2017
Compensation:
Job category:Process Development
Employment type:Full time
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Job Description


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Process Engineer II/III, MDI Manufacturing
Support Pearl MDI product development from product definition stages to product approval and launch by devising, leading, and conducting MDI manufacturing and process development.

Responsibilities
• Design experiments and conduct MDI manufacturing in support of Pearl MDI Process, Product and Platform Development. Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from technicians.
• Manufacturing planning, reviewing/writing protocols and reports and manufacturing batch records. Prepares product and process reports by collecting, analyzing, and summarizing information and trends indicative of aerosol product performance, process performance and equipment performance.
• Under general guidance, develop and implement instrumentation qualifications and standard operating procedures. Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures. Participate in training and guidance of technicians to drive quality and compliance for manufacturing activities.
• Under guidance, participate in development of regulatory submissions.
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Job Requirements


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Requirements
• MS –2 + years, BS – 7 + years in Chemistry, Pharmaceutical Sciences or a similar applicable discipline.
• ME – 1+ year, BE – 5 + years in Chemical Engineering or a similar applicable discipline.
• Experience with inhalation products preferred, especially MDIs, with a variety of active pharmaceutical ingredients at different stages of development.
• In-depth knowledge in one or more relevant fields: Process Engineering, Formulation Development, GMP Manufacturing.
• In-depth knowledge in the use, maintenance and applications of MDI filling equipment.
• Experience with controlled documents, documents for regulatory submissions and knowledge of GMP requirements is desired.
• Knowledge of relevant ICH, USP, EP, and FDA guidance documents as well as cGXPs in support of MDI product manufacturing and testing is desired.
• Must be able to effectively communicate verbally and through technical writing (documentation of laboratory experiments).

Physical Demands & Work Environment
Must be able to operate a PC and sit for extended periods of time. Some lifting required (not more than 50 lbs.). Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be willing to shave facial hair for respirator use as part of lab responsibilities as needed.

This position description intends to describe the general nature and level of work being performed by people assigned to this job. It is not intended to include all duties and responsibilities. The order in which duties and responsibilities are listed is not significant.
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