PRODUCTION/MANUFACURING ENGINEER

Fast growing manufacturer of single use products for the Bio-Pharmaceutical Process Industry has immediate need for a bright, energetic Production/Manufacturing Engineer. Excellent opportunity for advancement and to be part of our  team.

 



RESPONSIBILITIES:

Responsible for maintaining & Managing production schedules via manufacturing operation system, estimate staffing requirements, manufacturing capabilities, arrange for purchase of open order materials/equipment, and other considerations to facilitate production processes.

 

Plans, directs, and coordinates manufacturing processes in biopharmaceutical product development company: Develops, evaluates, and improves manufacturing methods, utilizing knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality control standards. Analyzes and plans work force utilization, space requirements, workflow, design layout of equipments for maximum efficiency. 

 

Establish standard production rate by observing time, motion, methods, and speed involved in maintenance, production, and other operations to improve efficiency. Applies statistical methods to estimate future manufacturing requirements and potential. Generate validation documents including protocols (IQ, OQ, and PQ) for process systems, Equipment, Facilities and Utilities. Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization. Review and approve the related documentation including Deviations, Investigations, Process and Project Descriptions, System Documentation and Drawings. This position requires of you to develop SOPs and other programs defining documents where required.

 

REQUIREMENTS:

 BS in Engineering with min. +5 years experience in an FDA, cGMP or ISO environment (Medical Device or Pharmaceuticals)

 Injection molding experience with thermoplastics

 Working experience with Great Plains or other MRP software.

 Self Starter and results oriented ?Ability to get the job done?

 Knowledge of world class quality systems and requirements

 Excellent Organizational skills.

 

Must be articulate and able to interact with all departments.

 

ALL RESPONSES MUST INCLUDE COVER LETTER AND SALARY HISTORY TO BE CONSIDERED.