Process Engineer

PROCESS ENGINEER

My client, a leader in the healthcare industry is looking for a full-time Process Engineer to join their team.

As an Engineer within Production and Logistics, you would responsible for designing, developing and implementing process improvements, to include development and drafting of process validation protocols, in accordance with applicable regulatory requirements. The Engineer also ensures that all activities are compliant with FDA Good Tissue (GTP)/ Good Manufacturing Practices (GMP), ISO regulations, and AATB standards.

You would be expected to perform all tasks assigned to you, including but not limited to:

• 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.
• 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.
• 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.
• Investigates assigned complaints and errors, conducting associated root cause analysis and implementing effective corrective actions.
• Trains Production and Logistics staff on process changes prior to implementation.
• 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

Minimum Qualifications:

• Bachelor’s in Engineering.
• 3 years of experience in a manufacturing or production environment.
• Must demonstrate advanced knowledge of computer programs (MS Project, word processing, spreadsheets, and presentations).
• Demonstrated strength with analytics and problem solving.
• Ability to manage numerous projects and meet deadlines as required.

Preferred Qualifications:

• Previous experience in tissue processing and/or medical device industry.
• Previous experience with AutoCad/SolidWorks.
• Previous experience with FDA, QSR/GMP and ISO regulations.