Nature and Scope
Working as part of a multi-disciplinary team, the Production Engineer II must possess the ability to manage multiple tasks simultaneously, manage projects and project timelines, and create project specific documentation, drive project procurement, implementation, and project closure in an FDA regulated environment. This position will be required to develop procedures and systems to assure operations and maintenance meet GMP and operational efficiency requirements as well as lead efforts to identify opportunities for operational improvement and possess the ability to solve technical issues that arise. This position will support both our commercial manufacturing as our Hilliard and New Albany locations. This position is a hands-on position and will focus on supporting equipment and processes required to support an aseptic manufacturing operation. This individual must possess a willingness and ability to grasp new concepts and systems quickly and provide Subject Matter Expertise on those systems once knowledge is acquired. This position requires the ability to chair meetings, present topics to the leadership team, provide constant, thorough and professional communication throughout all levels of the organization.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
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Work with manufacturing personnel to develop, review, revise, and maintain SOPs, operational, maintenance for all current process / filling equipment and maintenance processes.
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Develop and work with Maintenance in developing a spare parts inventory.
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Provide troubleshooting on process equipment / filling equipment issues.
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Assist and direct vendors and contractors as required on equipment within area of responsibility.
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Assure up-to-date drawings of new and/or existing equipment and processes.
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Assure compliance to GMP requirements, adherence to SOPs and use of the change control system.
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Assure all process and filling equipment operates within parameters.
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Create and maintain key performance indicator for process/filling equipment to maximize production efficiency.
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Create and manage the scope development of projects/tasks (User Requirement Specifications).
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Support new production and development equipment through vendor activities during installation, commission and qualification activities.
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Closely interact with the maintenance technicians to develop, implement, and improve maintenance practices and procedures.
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Identify and track key process metrics to identify improvement opportunities.
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Support Shut down activities and scheduling of process improvement work.
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Increase process equipment availability through reduction of breakdowns.
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Develop and implement improvements through cross-functional interactions.
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Support Quality Assurance investigations of process issues.
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Develop, conduct and document test methods for process systems troubleshooting.
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Facilitate completion of change control documentation.
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Develop training modules; provide coaching/feedback to develop/enhance technical personnel capabilities.
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Assist with EHS activities when applicable and appropriate.
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Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
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Bachelors’ Degree in Engineering, related discipline or equivalent experience required.
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Minimum of 5 years’ experience in Pharmaceutical, Manufacturing, or similar regulated environment.
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Ability to understand mechanical drawings, electrical/pneumatic schematics, process flow.
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Ability to troubleshoot process and mechanical systems (PLC experience a plus).
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Experience with customer interaction and coordination.
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Ability to prepare technical documentation / protocols.
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Computer proficiency (Microsoft Suite).
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Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
Physical Environment and Requirements
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Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.
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Employee must be able to occasionally lift and/or move up to 25 pounds.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
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