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Manufacturing Engineer Intern

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Aprecia Pharmaceuticals, LLC


General Purpose of Position:
The focus of this position will be in support of department personnel in carrying out routine tasks. Additionally, this position will be involved with developing new or modifying existing documentation to improve training retention and proper equipment setup and operation. Finally, this position will be expected to collaborate closely with other departments (i.e. Technical Services, Pharmaceutical Development, Operations Engineering, etc.) in cross functional company initiatives in carrying out the duties and responsibilities listed below.

Primary Duties and Responsibilities (Essential Functions):
Duties/Responsibilities1Develop and utilize working knowledge of unique manufacturing processes and equipment to support general Manufacturing function, including but not limited to:
  • Update existing, or create new, SOPs (standard operating procedures)
  • Update existing, or create new Master Batch Records
  • Update existing, or create new Production Trial Records
  • Facilitate activities, within Operations, associated with new products or technologies
  • Facilitate the development of work instructions as required to support operations, trials, or process improvements
2Work closely with Product Development and Technical Services departments on process improvement and technology transfer tasks and initiatives.3Provide support to the production floor in equipment operation and/or cleaning.4Provide support in investigations as required with troubleshooting equipment issues and non-conformance items as well as drafting CAPA and Deviations, as necessary.5Work with equipment vendors/manufacturers for troubleshooting and/or equipment improvement purposes6Review completed Batch Manufacturing and Packaging Records for completeness and accuracy in accordance with cGMP and site Standard Operating Procedure requirements and upload scans to appropriate electronic storage locations.7Log key processing information from executed Batch Manufacturing and Packaging Records into relevant database(s).8Support Production Supervisor in maintaining stock and ordering of general production supplies.9Support routine production housekeeping as required.10Generate documentation and systems for training to facilitate proper equipment setup and operation in all functional areas.11Other duties as assigned.
Reporting to this Position:
No direct reports

Position may require minimal travel

Work Shift:
Routinely works days, but availability to support/monitor Operations on off-shifts on a limited basis (10-25% maximum) is required

Knowledge, Skills and Abilities:
  • Strong problem-solving and critical thinking skills
  • Good computer and math skills required in order to reconcile and analyze production data.
  • Good oral and written communication skills required.
  • Ability to contribute to the development and updating of production batch records and SOPs.
  • Ability to participate in the investigation of non-conformance reports.
  • Ability to lead by example, leading small project teams while being part of a larger team in other efforts.
  • Intermediate proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook) required
Education and Experience:
  • High school degree or equivalent required
  • Working towards a B.S. degree in Engineering, Science, or a related discipline required
  • Manufacturing background and 3rd and 4th year students with previous intern experience preferred
Physical Demands and Work Environment:
  • Ability to stand for extended periods of time
  • Ability to lift and maneuver up to 50 pounds
  • Good eyesight to detect equipment or other manufacturing issues, to write and review SOPs, and read other technical/business documents
  • Awkward body positions (kneeling, bending, reaching) while performing work responsibilities
  • Ability to wear PAPR (powered air purifying respirator) or N95 respirator, as well as overgowning, steel shoes, gloves, etc., for an extended period of time
  • Exposure to chemicals, reagents, and other manufacturing/pharmaceutical products in the performance of regular job duties

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: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain
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