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Production Engineering Specialist
2 months ago
Position Overview:
The Production Engineering Specialist will oversee the procurement, installation, validation, preventative upkeep, and operational support of all manufacturing equipment systems. This role emphasizes enhancing efficiency for streamlined production and achieving industry-leading equipment reliability and availability through effective maintenance strategies and in-house spare part management.
Key Responsibilities:
- Comply with company policies and established operational procedures.
- Design facility layouts for equipment, materials, and workspaces to maximize productivity.
- Develop and uphold validation protocols and documentation (IQ, OQ, PQ) related to equipment setup and functionality.
- Identify and manage spare parts inventory and planning for equipment.
- Establish and maintain a Preventative Maintenance program aimed at ensuring both short-term and long-term equipment reliability for production.
- Actively participate in the identification, justification, procurement, validation, and implementation of capital equipment investments.
- Collaborate closely with facilities and operations teams to address mechanical and electrical equipment needs, minimizing downtime.
- Assist quality assurance in the creation and maintenance of product Master Batch Records for precise material and product traceability.
- Support company systems to accurately gather data on material usage, inspection methods, inventory, storage, shipping, and personnel training.
- Provide training on manufacturing procedures to operations staff.
- This role will support both animal and human product processing with a focus on equipment maintenance and uptime.
Required Qualifications:
- Bachelor's Degree in Engineering, preferably in Manufacturing or Mechanical, or equivalent relevant experience (minimum 5 years preferred).
- Prior experience in the food, medical, supplement, or manufacturing sectors is preferred.
- Extensive experience in FDA, GMP, and ISO environments is preferred.
- Significant experience with Liquid Filling, Dry Powder Mixing and Filling, Confectionary, Bottling and Labelling, and Encapsulation systems is preferred.
- Experience in both low volume/high complexity and low complexity/high volume production settings.
- Familiarity with Statistical Process Control (SPC) and process control methodologies.
- Ability to organize and manage multiple projects effectively.
- Capability to work with allergens as defined by regulatory standards.
Managerial Responsibilities:
This position includes some hiring, training, and supervisory duties, along with responsibility for tasking and overseeing indirect reporting personnel.
Travel Requirements:
Occasional overnight travel may be necessary; expected to be less than 20% of the time.
Work Authorization:
Must possess authorization to work in the United States.
Physical Demands and Additional Duties:
This role involves physical demands, including frequent lifting and/or moving of materials weighing between 10-50 pounds. While performing job duties, the employee may encounter fumes, airborne particles, moving mechanical parts, vibrations, and high noise levels. Knowledge and adherence to safety practices and personal protective equipment usage are essential.
