Manufacturing Process Engineer

Nature and Scope The Process Engineer must effectively manage multiple projects, including project timelines, documentation, procurement, implementation, and closure in an FDA regulated environment. The Process Engineer will be required to develop procedures and systems to assure that manufacturing operations and maintenance meet Current Good Manufacturing Practices (cGMP), operational efficiency requirements, and lead efforts to identify opportunities for improvement.

The Process Engineer will support commercial manufacturing, Research & Development, and Validation operations as required. The Process Engineer is a hands-on position that will focus on the equipment and processes that support aseptic manufacturing, inspection, and packaging operations.

The Process Engineer will provide Subject Matter Expertise in their area, as well as chair meetings, present topics to the leadership team, and provide constant, thorough, and professional communication to all levels of the organization.

Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Assure compliance with cGMP requirements and adherence to Standard Operating Procedures (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 recommendations (i.e. new process equipment, equipment justification to improve performance).Ongoing strategic evaluation of the existing product portfolio with the objective of optimizing profitability through product modification, supply base management/alignment, and Supply Chain Methods improvement.

Ability to successfully assemble, lead, and manage a cross-functional value analysis team demonstrating an ability to deliver site and corporate savings goals.

Provide key performance indicator data (i.e. production control charts, reliability, process capability), to improve the process and monitor and measure progress to target.

Support new production and development equipment through vendor activities during installation, commission, and qualification activities (I/O/PQ).Closely interact with the maintenance technicians to develop, implement, and improve maintenance practices and procedures.

Identify, generate, and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations in a cGMP environment.

Collaborate with other relevant departments to determine estimated costs, run time, cost reduction, and provide feedback via video loops.

Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

Bachelor’s degree in the sciences or engineering, required. Manufacturing Engineering (ME) or Industrial Engineering (IE) degree, preferred.

Minimum 3 years’ experience in a field related to 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 computer assisted design 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 Standard…