Sr Manufacturing Engineer (Nutraceuticals) - Keystone & Golden, Inc.

The Senior Manufacturing Engineer will be responsible for the sourcing, installation, validation, preventative maintenance, and operations support of all operations equipment systems. This position will drive equipment, continuous improvement efforts, enhance overall production improvements, create metrics to track equipment uptime and availability, FMEA, and process optimization. The Senior Manufacturing Engineer will work closely with internal team members from Quality, Facilities and Operations to optimize final product yields and exceed customer expectations.

Essential Functions:

• Adhere to company Policies and Standard Operating Procedures
• Optimize and enhance manufacturing processes for improved efficiency, quality, and safety.
• Align Engineering projects with strategic goals, particularly those related to capacity, efficiency, and sustainability.
• Collaborate with third party vendors as required for new projects and expansion lines success.
• Source new equipment for various projects to include packaging, handling, and transport of materials.
• Work closely with the Production Management team to identify and capitalize on opportunities for process improvement.
• Develop and update written Standard Operating Procedures (SOPs).
• Provide technical support and expertise, ensuring a smooth and efficient process development, scale up and manufacturing transfer of several dosage forms including capsules, gummies, tablets, and powders.
• Lead or assist in the development of new equipment installations or modifications, from concept to commissioning, with a focus on maximizing output, minimizing downtime, and reducing operational risk.
• Utilize data analysis and statistical techniques to identify bottlenecks, process variability, and areas for improvement in production processes. Implement data-driven solutions to increase overall efficiency while mitigating operational risk and collaborating with Process Excellence and Data Science to refine analytics models.
• Conduct Failure Modes and Effects Analysis (FMEA) to proactively identify potential failure points, risks, and weaknesses in processes and equipment. Develop strategies to reduce operational risk and enhance process reliability.
  

Required Education and Experience:

• Bachelor’s degree in engineering or Engineering Technology, preferably Manufacturing, Mechanical, Industrial, or any engineering related field.
• 8+ years in Engineering and equipment experience.
• Previous experience in the food, medical, supplement or manufacturing industries preferred.
• Significant experience with FDA, GMP, HACCP, and ISO environment preferred.
• Must have significant experience with Liquid Filling, Dry Powder Mixing and Filling, Confectionary, Gummy manufacturing, Bottling and Labelling and Encapsulation systems preferred.
• Experience in low volume/high complexity and low complexity/high volume production environments.
• Working familiarity with SPC and process control methodologies.
• Ability to organize and manage multiple projects.

Manager Responsibility:

• This position will have some hiring, training, and supervisory responsibilities, and will be responsible for tasking and supervising indirect reporting personnel

Travel:

• Occasional overnight travel as required; should not exceed 20% of time