Process/Project Engineer II

Nitto Denko Corp.•Milford, MA

About The Position

This position provides engineering support for manufacturing and facility related activities throughout the organization. Responsible for client project team support, transfer of new processes to manufacturing, equipment and facility troubleshooting, validation of new equipment, and support of Continuous Improvement and cost reduction efforts. The position is also responsible for design and purchase new process equipment and will manage large capital projects.

Requirements

B.S. Degree in Chemical, Mechanical or Electrical Engineering.
Knowledge of pharmaceutical unit operations, general mechanical/electrical engineering concepts, process and equipment design, controls hardware/software, and an understanding of GMP regulations.
Preferred 5 years of manufacturing support with minimum of 2 years in a chemical API environment.
Hands-on ability to start-up and troubleshoot of equipment
Ability to facilitate and lead cross-functional teams

Responsibilities

Provide engineering support and guidance to Manufacturing, Facilities and Validation.
Create Engineering documentation including technical reports, specifications, URDs, CAD drawings, and ETOPs.
Create and revise equipment SOPs, preventive maintenance procedures and other documents needed to support equipment operation.
Participate in client project teams as the Engineering representative.
Responsible as a first line responder on equipment issues during manufacture which includes being available on-call for emergency support.
Obtain expert knowledge on process equipment.
Train technical personnel in the use, care and safe operation of manufacturing/facilities assets.
Collaborate with necessary departments to investigate and close CAPAs and resolve production problems.
Provide technical oversight and lead the FMEA and business risk management process.
Lead and participate in Continuous Improvement efforts to improve efficiency and reduce cost.
Coordinate large capital projects and oversee internal cross-functional teams, vendors and contractors to ensure that projects remain on time and within budget.
Lead and participate in Continuous Improvement efforts to improve safety, quality, and efficiency and to reduce cost.