Manufacturing Engineer
Description
By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
Pay Range:
$58,300.00 - $95,800.00
Position Summary
The Manufacturing Engineer assists in the plan, design, and maintenance of manufacturing processes. Ensure systems are running according to specifications in the production of quality product. Determine parts and tools required for Manufacturing to achieve their goals of producing quality products. Develop process documentation and validations that meet applicable regulatory standards. This position requires close collaboration with the Formulation & Filling, Packaging, Materials, Q.C. and R&D departments. The ability to set project schedules and meet appointed deadlines is required.
Responsibilities
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Generate, develop, and execute validation protocols for manufacturing and packaging equipment.
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Develop and modify procedures to streamline processes and improve product quality.
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Participate in process development for new products being transferred to manufacturing.
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Hands-on Manufacturing equipment troubleshooting and diagnosis. Follow through with documented procedure changes and required ECOs.
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Research, design, specify, and procure required process and automated packaging equipment.
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Qualify and validate new suppliers and materials. Generate required validation protocols and Engineering Change Orders (ECO)
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Collaborate with Quality Assurance to complete root cause analysis for CAPAs/Complaints and implement corrective/preventive actions.
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Generate material specifications for new parts.
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Manage multiple projects w/minimal supervision. Maintain projects on a schedule to meet predetermined deadlines.
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Follows company policies and practices as outlined in the Handbook, SOPs and SWIs and as well as follows guidelines regarding safety as outlined in the safety program and in accordance to the job function.
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Manages time well and will put in extended time as needed.
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Willingness to accept changes in work from day-to-day within reasonable and expected boundaries.
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Perform other duties as assigned.
Qualifications
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A Bachelors degree in Engineering or related field is required.
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A minimum of 1-2 years hands on working experience in a regulated manufacturing environment is preferred.
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Strong verbal and written skills are required.
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Good understanding of cGMP and validation is preferred.
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Strong organizational skills are required.
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Individual must possess strong mechanical and electrical skills.
Minimum Physical Requirements:
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Remain seated in a normal position for extended periods of time up to 8 hours
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Walk, stand, and move for prolonged periods in a workday
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Reach up and out with hands and arms
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Talk and hear, verbally express information
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Keyboard, 10 keys,
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Repetitive motion; hands, arms
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Lift up to 25 pounds and carry a distance of 10 feet
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Use hands to grasp, hold, move and pickup objects continuously
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Ability to stoop or kneel for limited amounts of time
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Ability to climb ladders This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact [email protected] for assistance.