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in Virginia Beach, VA

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Hours Full-time, Part-time
Location Virginia Beach, VA
Virginia Beach, Virginia

About this job

The ideal candidate will be responsible for designing, developing and implementing process improvements, to include development and drafting of process validation protocols, in accordance with applicable regulatory requirements. Ensures that all activities are compliant with FDA Good Tissue (GTP)/ Good Manufacturing Practices (GMP), ISO regulations, and AATB standards. This position will require strong analytical skills and a systems approach to problem solving. Must embrace Lean concepts, drive continuous improvements, reduce costs, and are responsible for the development of lean systems and procedures.

Essential Functions of the Job

  • Leads and executes assigned projects of varying scope and complexity working with multi-department project resources in identifying and implementing process and equipment improvement opportunities.
  • Serves as the Production and Logistics technical resource for transferring new processes and products from Product Development. Has lead responsibility in the development of systems and project plans to include technical protocol development while providing guidance to other members of the assigned team.
  • Trains Production and Logistics staff on process changes prior to implementation.
  • Investigates assigned complaints and errors, conducting associated root cause analysis and implementing effective corrective actions.
  • Troubleshoots equipment related problems and performs installation, operational, and post repair qualification of equipment as needed. Creates associated required documentation.
  • Develops and/or executes process validation protocols in accordance with generally accepted regulatory principles.
  • Develops, monitors and routinely reports key engineering performance indicators and objectives to ensure continuous improvement and timely completion of tasks/projects. Assists in setting department goals and objectives
  • Maintains costs within budget.

Qualifications:

  • MUST HAVE a Mechanical Engineering Degree
  • 1-3 years manufacturing engineering experience (Master's Degree: 0-3 years experience).
  • Demonstrated proficiency in lean manufacturing concepts, process development and process validation preferred.
  • Strong working knowledge of FDA QSR/GMP and ISO regulations preferred
  • Strong analytical and problem solving skills.
  • Proficient in Microsoft Office applications including MS Project and Visio
  • Trained in Six Sigma/ LEAN principles and methodologies and or Design for Six Sigma (DFSS) preferred.
  • Ability to manage numerous projects and meet deadlines as required.
  • Excellent verbal and written communication skills




About Aerotek:


Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .

Aerotek is acting as an Employment Agency in relation to this vacancy.