Description

RESPONSIBILITIES:

  • Responsible for process development, equipment specification, acquisition and implementation.
  • Works to identify root cause of manufacturing failures using structured problem solving. Applies root cause fixes to prevent reoccurrence.
  • Evaluates machine logic, electromechanical systems and process controls to troubleshoot equipment.
  • Completes design of experiments, validation, completion of testing and analysis of data for continuous improvement activities. Presents data to equipment teams.
  • Suggests and supports new methods or materials for continual improvement of quality and efficiency.
  • Analyzes current equipment for process suitability and provides detailed plans for improvement
  • Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient and safe procedures
  • Works with other engineers and technicians in developing solutions and improvements in materials, equipment and process as necessary
  • Participates in teams as necessary to ensure continual improvement, safety and compliance
  • Provides training and process expertise for product processing in specific areas such as process development, tooling development and validation.
  • Manages engineering project teams and coordinates activities.
  • Mentors junior engineers and maintenance technicians.
  • Initiates and works to resolve Quality Incidents and CAPA.
  • Ability to travel up to 25% of the time

 

BASIC QUALIFICATIONS | EDUCATION:

  • Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
  • Minimum three years engineering experience in a manufacturing environment
  • Familiarity with a variety of material testing and measuring methods.
  • Knowledge of Database software; CAD software; Development software; Internet software; Inventory software; Manufacturing software; Project Management software; Microsoft Excel software and Microsoft Word software.

 

PREFERRED QUALIFICATIONS:

  • Experience working in a GMP, FDA, ISO and USDA regulated environment.
  • Familiarity with cGMP and ISO 13485 regulations and practices.
  • with statistical analysis software (Minitab).

COMPETENCIES:

  • Ability to work with mathematical concepts such as ANSI/AQL, probability and statistics.

Education

Any Graduate