Manufacturing Process Engineer

American Regent, Inc.•Shirley, NY

7d•$91,000 - $100,000

About The Position

The Process Engineer manages multiple projects in an FDA-regulated environment, including timelines, documentation, procurement, implementation, and closure. The role develops procedures and systems to ensure manufacturing operations and maintenance meet current Good Manufacturing Practices (cGMP) and operational efficiency requirements, and leads efforts to identify opportunities for improvement. The position supports commercial manufacturing, Research & Development, and Validation operations as needed. It is hands-on and focuses on equipment and processes supporting aseptic manufacturing, inspection, and packaging. The Process Engineer provides subject matter expertise, chairs meetings, presents topics to leadership, and communicates professionally across the organization.

Requirements

Bachelor’s degree in science or engineering.
At least 3 years of experience in a field related to manufacturing or industrial engineering.
Ability to read Standard English documents such as SOPs, maintenance schedules, and operating manuals.
Ability to wear cleanroom and protective gowning and equipment.
Ability to occasionally lift and/or move up to 50 pounds.

Nice To Haves

A degree in Manufacturing Engineering (ME) or Industrial Engineering (IE).
Experience in pharmaceutical manufacturing.
Lean Six Sigma certification.
Experience writing technical documentation and protocols, such as SOPs, NOEs, and CAPAs.
Experience with computer-assisted design software, such as MS Project, AutoCAD, Solidworks, or Visio.
Experience operating parenteral manufacturing equipment.

Responsibilities

Assure compliance with cGMP requirements and adherence to Standard Operating Procedures (SOPs).
Create and manage project scope.
Perform Factory Acceptance Testing (FAT) of manufacturing equipment.
Improve operations to increase quality, productivity, and efficiency and reduce costs.
Investigate operational problems affecting production, report findings, and recommend solutions.
Recommend ways to reduce production costs, including new process equipment and equipment improvements.
Evaluate the existing product portfolio strategically to optimize profitability through product modification, supply-base management and alignment, and Supply Chain Methods improvement.
Assemble, lead, and manage cross-functional value analysis teams to deliver site and corporate savings goals.
Provide key performance indicator data, including production control charts, reliability, and process capability, to improve processes and monitor progress toward targets.
Support new production and development equipment through vendor activities during installation, commissioning, and qualification (I/O/PQ).
Work with maintenance technicians to develop, implement, and improve maintenance practices and procedures.
Identify, generate, and manage implementation of change controls to improve processes and address investigation root causes in a cGMP environment.
Collaborate with relevant departments to determine estimated costs, run time, and cost reductions, and provide feedback via video loops.
Perform other tasks and duties as assigned by management.