Manufacturing Engineer

Role Summary

The Manufacturing Engineer assists in the plan, design, and maintenance of manufacturing processes to ensure systems run according to specifications and within regulations in the production of quality products. This role involves determining parts and tools required for manufacturing to meet GMP and ISO standards, and requires close collaboration with Formulation & Filling, Packaging, Materials, QC, and R&D. The ability to set project schedules and meet deadlines is required.

Responsibilities

• Generate, develop, and execute validation protocols for manufacturing and packaging equipment.
• Develop and implement new COBOT (collaborative robots) systems.
• Identify, develop and implement vision systems.
• Develop new and robust procedures to aid in streamlining and improving product quality.
• Participate in process development for new products being transferred to manufacturing.
• Hands-on Manufacturing equipment troubleshooting and diagnosis. Follow through with documented procedure changes and required ECOs.
• Research, specify and procure required process and automated packaging equipment.
• Qualify and validate new suppliers and materials. Generate required validation protocols and Engineering Change Orders (ECO).
• Generate material specifications and inspection records for new parts.
• Focus on balancing production and reduction of production waste.
• Manage multiple projects with minimal supervision. Maintain projects on a schedule to meet predetermined deadlines.
• Follows company policies and practices as outlined in the Handbook, SOPs and Wis.
• Manages time well and will put in extended time as needed.
• Willingness to accept changes in work from day-to-day within reasonable and expected boundaries.
• Perform other duties as assigned.

Qualifications

• Required: A bachelor’s degree in engineering or related field
• Preferred: A minimum of 1-2 years hands-on working experience in a regulated manufacturing environment
• Required: Strong verbal and written skills
• Preferred: Good understanding of cGMP and validation
• Required: Strong organizational skills
• Required: Individual must possess strong mechanical and electrical skills

Skills

• Knowledge of value stream mapping
• Kaizen methodology
• Promote teamwork across other departments
• Detail-oriented and capable of accurate, organized work
• Proficient in Microsoft Office (Excel, Word, Smartsheet)
• Ability to communicate effectively with development, manufacturing, production, financial, customer service, sales, and marketing personnel

Education

• Bachelor’s degree in engineering or related field