Process Engineer II

Polysciences technical operations and scientific laboratories offer custom synthesis, contract manufacturing and packaging, and laboratory products.

We are proud to offer a broad range of products and tailored solutions for the life sciences, bioprocessing, microparticles, medical device, specialty chemical and eChem industries.

We adhere to ISO13485:2016, FDA cGMP 21 CFR 820 regulations, and SOCMA’s ChemStewards® Management System.

We believe the best scientific innovations are built through collaborations.

The Process Engineer II is responsible for optimizing and monitoring processes and systems.

The Process Engineer II works with the R&D team to transfer early stage products into the production area to create the commercial process.

They are responsible for implementing improved processes for more efficient production.

They are also responsible for system design, implementation and oversite to facilitate and sustain process improvements. 

Essential Functions: Fundamental and critical tasks, duties, and responsibilities necessary for position to be performed effectively.


* Support commercial production and online troubleshooting for both the process and associated equipment.



* Design, develop, implement and as needed, oversee systems to improve and sustain commercial manufacturing, cleaning, filling and packaging processes.



* Work collaboratively with a cross functional team (R&D, Quality, QC, Production, EHS, etc.) to ensure improvements align with required design and development process. 



* Author supporting process development documents such as SOPs, IOQs, Batch Records, Protocols and Reports.



* Assist in Nonconformance and OOS investigations to drive to root cause and implement effective CAPAs to mitigate repeat events.



* Lead a cross functional team for implementation of new processes, systems, equipment, etc. 



* Define, procure, install and qualify manufacturing equipment for commercial production.



* Lead continuous improvement projects for established products and systems.


* Represent projects technically for customer calls and meetings as projects progress through development.

Qualifications

-Troubleshooting skills to support commercial production for both the process and associated equipment.

-Ability to design, develop, implement and as needed, oversee systems to improve and sustain commercial chemical manufacturing, cleaning, filling and packaging processes.

-Ability to work collaboratively with a cross functional team (R&D, Quality, QC, Production, EHS, etc.) to ensure improvements align with required design and development process.

-Bachelor’s degree in Chemical Engineering preferred, Industrial or Mechnical accetable.

-Experience working in an ISO 13485 or FDA GMP environment preferred. 

-A minimum of 2-5 years of engineering experience in a manufacturing environment or similar required.

-Familiarity with process scale-up, optimization, cleaning and validati...