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Manufacturing Engineer I

Blue Ash, Ohio
General Purpose of Position: 
The focus of this position is working first-hand on the development and implementation of new processes, procedures, initiatives, and best practices. This position will be the subject matter expert for the manufacturing department on all existing and new equipment operations and will champion training of manufacturing personnel on new pieces of equipment as they are brought online. This position will also be responsible for analyzing trends during the forming process and identifying any machine adjustments and process improvements as required.  

Primary Duties and Responsibilities (Essential Functions):

1    Develop 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) in document control system
•    Update existing, or create new Master Batch Records
•    Author and manage Change Controls associated with new or existing equipment
•    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
•    Support capital projects within Manufacturing, as required
2    Apply knowledge of operational efficiency, including Overall Equipment Effectiveness (OEE), including but not limited to:
•    Understand the components of OEE and the operational influences for improving performance 
•    Utilize OEE data to recommend process improvements 
•    Lead process improvement activities within Manufacturing
3    Work closely with product development and technical services departments on process improvement and technology transfer activities and project management.
4    Leverage full working knowledge of the Maintenance Work Order system and be able to navigate through work orders and generate/analyze system reports for data analysis or trends
5    Identify trends during forming and recommend adjustments as needed
6    Provide leadership and support to the production floor in equipment operation
7    Provide support in investigations as required with troubleshooting equipment issues and non-conformance items as well as drafting CAPA and Deviations as necessary.
8    Champion and/or track progress on projects in the manufacturing area as they relate to processes and equipment operation
9    Support the manufacturing management in periodic review of existing and new revisions to manufacturing documentation in regards to (but not limited to): Operation, Technical Accuracy, Compliance, Process Robustness, etc.
10     Work with equipment vendors/manufacturers for troubleshooting and/or equipment improvement purposes

Reporting to this Position:
No direct reports

Position may require 10-25% 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:
•    Demonstrated success working in a team environment 
•    Knowledge of process control techniques, maintenance procedures, and safe work practices related to equipment operation and chemical handling
•    Knowledge of cGMPs essential
•    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
•    Bachelor’s degree in an engineering based discipline or equivalent work experience required 
•    Two (2) or more years of experience in a cGMP environment is preferred
•    Previous solid dosage pharmaceutical experience preferred
•    Knowledge of Lean Manufacturing techniques and experience with Kaizen and 5S events is a plus

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 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, sexual orientation, gender identity, national origin, disability or veteran status.

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