Aseptic Process Engineer - cGMP & Lean Improvements

AMERICAN REGENT, INC.; Shirley (NY); Presencial; USD 91.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare

Life insurance

Profit sharing

Paid time off

401k matching

Descripción de la vacante

American Regent, Inc. is seeking a Process Engineer to manage multiple projects in an FDA-regulated environment and to drive continuous improvement across aseptic manufacturing, inspection, and packaging operations.

You will lead cross-functional teams, develop procedures and systems to meet cGMP, and present findings to leadership. The role requires hands-on work on equipment, FAT, and collaboration with maintenance and R&D.

Formación

• Bachelor’s degree in the sciences or engineering.
• Manufacturing Engineering (ME) or Industrial Engineering (IE) degree, preferred.
• Minimum 3 years’ experience in manufacturing or industrial engineering, required.
• Pharmaceutical manufacturing, preferred.
• Lean Six Sigma certification, preferred.
• Experience writing technical documentation/protocols (i.e. SOP, NOE, CAPA).
• Experience with CAD software (i.e. MS Project/AutoCAD/Solidworks/Visio), preferred.
• Experience operating parenteral manufacturing equipment, preferred.
• Must be able to read documents in Standard English such as SOPs, maintenance schedules, and operating manuals.

Responsabilidades

• Assure compliance with cGMP requirements and adherence to SOPs.
• Create and manage the scope of projects.
• Perform Factory Acceptance Testing (FAT) of manufacturing equipment.
• Improve operations for increased quality, productivity, efficiency, and cost savings.
• Investigate operational problems affecting production; report and recommend solutions.
• Identify ways to reduce production costs through new process equipment and equipment justification.
• Strategic evaluation of existing product portfolio to optimize profitability.
• Assemble, lead, and manage a cross-functional value analysis team.
• Provide KPI data to improve processes and monitor progress to target.
• Support new production and development equipment through vendor activities (I/O/PQ).
• Collaborate with maintenance to improve practices.
• Implement change controls to improve processes in a cGMP environment.
• Collaborate with departments to estimate costs and run times; provide feedback.

Conocimientos

cGMP knowledge

SOP writing

Educación

Bachelor’s degree in sciences or engineering

Manufacturing Engineering or Industrial Engineering

Lean Six Sigma certification

Herramientas

MS Project

AutoCAD

Solidworks

Visio

Descripción del empleo

American Regent, Inc. is seeking a Process Engineer to manage multiple projects in an FDA-regulated environment and to drive continuous improvement across aseptic manufacturing, inspection, and packaging operations.

You will lead cross-functional teams, develop procedures and systems to meet cGMP, and present findings to leadership. The role requires hands-on work on equipment, FAT, and collaboration with maintenance and R&D.