Manufacturing Process Engineer

American Regent•Shirley, NY

13d

About The Position

The Process Engineer manages multiple projects in an FDA-regulated environment, including timelines, documentation, procurement, implementation, and closeout. The role develops procedures and systems to ensure manufacturing operations and maintenance meet cGMP requirements and operational-efficiency goals, and leads efforts to identify improvement opportunities. The engineer supports commercial manufacturing, Research & Development, and Validation operations as needed. This is a hands-on role focused on equipment and processes supporting aseptic manufacturing, inspection, and packaging. The Process Engineer serves as a subject matter expert, chairs meetings, presents topics to leadership, and communicates professionally and thoroughly across the organization.

Requirements

Bachelor’s degree in a science or engineering field.
At least 3 years of experience in a field related to manufacturing or industrial engineering.
Experience writing technical documentation and protocols, such as SOPs, NOEs, and CAPAs.
Ability to read documents in Standard English, including SOPs, maintenance schedules, and operating manuals.
Ability to perform the essential duties satisfactorily.

Nice To Haves

Manufacturing Engineering or Industrial Engineering degree.
Pharmaceutical manufacturing experience.
Lean Six Sigma certification.
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.
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 justifications to improve performance.
Evaluate the existing product portfolio strategically to optimize profitability through product modification, supply-base management and alignment, and improved supply-chain methods.
Assemble, lead, and manage cross-functional value-analysis teams to deliver site and corporate savings goals.
Provide key performance indicator data, such as production control charts, reliability, and process capability, to monitor progress and improve processes.
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 appropriate 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 assigned by management.