Production Engineer jobs in Kearney, NE

Job Description

This position is responsible for leading the activities and responsibilities associated with the day to day production of APIs, including production tracking and scheduling; shift instructions; troubleshooting; lock out tag out (LOTO) and safety oversight; and on call activities for manufacturing support. Incumbent will be the subject matter expert and provide leadership to the operators in the assigned area. This role will also include planning, developing, and recommending approaches to implement projects for optimizing production capacity, capability, and quality, while also ensuring optimal levels of energy conservation and environmental improvements. This role will be responsible to oversee and maintain compliance with a unit that is OSHA PSM standard) covered and must be a SME in this area of process safety.

POSITION RESPONSIBILITIES:

• Monitor production trends by statistical analysis; react to problems, trends and opportunities within the production process.
• Monitor batch quality data for in-spec material and analyze data to assist with determining optimum batch yields (Statistical Analysis).
• Coordinate with Production, Microbiology Lab and Maintenance Departments to develop strategies to increase production, such as: improvement of potencies, reduction of costs, and process control.
• Be responsible for start-up validation and testing of units to pass production regulation requirements.
• Work with Regulatory Compliance group to create an effective Validation Plan.
• Provide troubleshooting and production support expertise for instrumentation, control technology, production equipment.
• Document Maintenance procedures on equipment.
• Develop, submit, manage, and implement capital orders for new or replacement equipment.
• Oversee contractors working on capital projects, ensuring that OSHA standards are met.
• Interface with Project and Refining Engineers, Production, Maintenance, and Plant labs to coordinate capital project work.
• Write operating instructions for production process changes.
• Ensure that new equipment is installed according to standards and protocols.
• Verify control schemes, interlocks, and safety devices designed by contractors.
• Maintain Distributive Control Systems and Programmable Logic Controllers in a valid state as required by the FDA.
• Size controlling and monitoring instrumentation when new equipment is installed.
• Train Production Operators in the proper operation of new equipment.
• Communicate with individuals at other facilities to coordinate process developments.
• Provide technical assistance and piloting for process startups, process modifications, and process problem trouble shooting.
• Work with Information Services Department to provide process data on the computer network for analysis by Engineering, Production and Laboratory personnel.
• Issue a weekly production plan to schedule fermenters and coordinate with procurement to ensure raw materials are available to meet said schedule.
• Schedule maintenance PM's in the area to maintain equipment in a validated state.
• Oversee LOTO and be act as the subject matter expert in the assigned area.
• Approve Time Cards for the hourly workforce in the area.
• Perform other duties as assigned.
• Maintain unit in a OSHA compliant state. Lead any audits/process safety reviews/ and be the PSM SME for the unit

EDUCATION AND EXPERIENCE:

• Bachelor's Degree in Engineering (Chemical Engineering preferred) or related technical degree.
• 3-5 years of production engineering experience is necessary, including responsibility for process development and validation.

TECHNICAL SKILLS REQUIREMENTS:

• Knowledgeable of PSM programs (OSHA
• Ability to independently plan and execute projects
• Ability to manage multiple tasks
• Strong interpersonal, oral and written communication skills
• Advanced mathematical, analytical and problem-solving skills
• PC literate with proficiency in Microsoft Office applications & Project software
• Excellent attention to detail
• Proven leadership skills and the ability to foster teamwork and cooperation
• Ability to lead joint vendor projects effectively
• A Green Belt in Six Sigma is desired
• Experience working in a dusty environment with explosion hazards.
• Experience in an FDA regulated facility is desired.
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, legal documents.
• Ability to write documents such as Standard Operating Procedures and PM's, routine reports, and correspondences in a concise and clear manner.
• Advanced material and problem-solving ability
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to speak effectively before groups of contractors, designers, consultants, employees, and/or senior leadership.
• Ability to perform math commensurate with a four (4) year Engineering degree requirement, i.e. algebra, geometry, calculus, trigonometry.
• Expertise in Minitab/Six Sigma is preferred.
• Must be able to access all areas of manufacturing plant.

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