Process Engineer

3 days ago

New Albany, Ohio, United States Bright Innovation Labs Full time
Job Title: Process Engineer

At Bright Innovation Labs, we are seeking a highly skilled Process Engineer to join our team. As a Process Engineer, you will be responsible for the overall ownership and performance of the Validations for the Facility, including evaluating processes in Compounding and Production related to the batching and filling of any existing products or formulas under future development.

Key Responsibilities:
  • Manage OTC Validation Program and Change Control Program including Process Validation and Equipment Validation, Maintenance of the completed validations.
  • Responsible to perform Installation and Operation qualification of all equipment.
  • Responsible for ensuring water system is compliant including validations of water system.
  • Writing and executing Cleaning Validation protocols for different equipment according to 21 CFR Part 110 (cGMP in Manufacturing, Packing or Holding Human Food).
  • Lead, design and execute all plant wide process scale-up activities from R&D scale through fully commercialized scale to assure compliance to product specification.
  • Lead and direct training activities for Compounding and Quality Control Personnel in areas related to batch processing.
  • Provide technical expertise for design and installation of new equipment and process related to batch manufacture.
  • Performs research, evaluates, designs, and develops manufacturing processes including product flow, storage of products and assembly methods for the compounding and production equipment.
  • Maintain reliable and safe manufacturing practices while improving batching reliability, mixing, and holding tank outages / yields, compounding rates and batching times, and wastewater costs.
  • Improve process capability and production volume while maintaining and improving quality standards.
  • Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
  • Assist Plant Manager and Department managers in improving systems related to compounding and production control.
  • Create, evaluate, and update all standard operating procedures for processes, equipment, quality, and safety related to the area of responsibilities.
  • Maintains product and company reputation by complying with federal and state regulations.
  • Promote compliance with Bocchi Laboratories' policies, procedures, quality standards and current Good Manufacturing Practices (cGMP) as well as safety and environmental regulations.
Requirements:
  • Bachelor's Degree in Process, Industrial, Chemical or Mechanical Engineering and 5 or more years' experience in Manufacturing with a background in plant layout, process development and manufacturing quality preferred.
  • Strong verbal, writing skills and communication skills.
  • Ability to speak, read, and write in English.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedure, or governmental regulations.
  • Ability to write reports, business correspondence and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
  • Must have a high level of competency working with computers and programs.
  • Professional Engineering Status or Engineering License required.
  • English language and knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
  • Must be authorized to work in the U.S. as a pre-condition of employment.

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